Ethicon Endo-Surgery Inc
Cincinnati, OH, US
ETHICON ENDO-SURGERY, INC. appears in FDA device records in Cincinnati, OH. FDA records list 185 510(k) clearances between and , no PMA records and 2 registered establishments. As of , FDA records show 178 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
Showing 50 of 185FDA records hold 185 510(k) clearances for Ethicon Endo-Surgery Inc between 1992 and 2026. The busiest year on record is 2001, with 13. The most recent is 2026, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1992 | 1 |
| 1993 | 6 |
| 1994 | 5 |
| 1995 | 6 |
| 1996 | 5 |
| 1997 | 11 |
| 1998 | 6 |
| 1999 | 10 |
| 2000 | 4 |
| 2001 | 13 |
| 2002 | 7 |
| 2003 | 6 |
| 2004 | 6 |
| 2005 | 5 |
| 2006 | 8 |
| 2007 | 6 |
| 2008 | 5 |
| 2009 | 6 |
| 2010 | 6 |
| 2011 | 6 |
| 2012 | 6 |
| 2013 | 9 |
| 2014 | 3 |
| 2015 | 3 |
| 2016 | 4 |
| 2017 | 4 |
| 2018 | 4 |
| 2019 | 2 |
| 2020 | 6 |
| 2021 | 3 |
| 2022 | 2 |
| 2023 | 4 |
| 2024 | 2 |
| 2025 | 3 |
| 2026 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K260196 | ETHICON™ Circular Stapler (CDH21mm); ETHICON™ Circular Stapler (CDH25mm); ETHICON™ Circular Stapler (CDH29mm); ETHICON™ Circular Stapler (CDH33mm); ETHICON™ Circular Stapler - XL Sealed (ECS21mm); ETHICON™ Circular Stapler - XL Sealed (ECS25mm); ETHICON™ Circular Stapler - XL Sealed (ECS29mm); ETHICON™ Circular Stapler - XL Sealed (ECS33mm) | GDW | Substantially Equivalent | |
| K252906 | ECHELON ENDOPATH Staple Line Reinforcement (ECH60R) | OXC | Substantially Equivalent | |
| K252739 | ETHICON™ 4000 45mm Compact Stapler (EC3DT45C); ETHICON™ 4000 45mm Standard Stapler (EC3DT45S); ETHICON™ 4000 45mm Long Stapler (EC3DT45L); ETHICON™ 3D 45mm White Reload (ER45W); ETHICON™ 3D 45mm Blue Reload (ER45B); ETHICON™ 3D 45mm Green Reload (ER45G); ETHICON™ 3D 45mm Black Reload (ER45T) | GDW | Substantially Equivalent | |
| K250835 | ETHICON 4000 60mm Compact Stapler (EC3D60C); ETHICON 4000 60mm Standard Stapler (EC3D60S); ETHICON 4000 60mm Long Stapler (EC3D60L); ETHICON 3D 60mm White Reload (ER60W); ETHICON 3D 60mm Blue Reload (ER60B); ETHICON 3D 60mm Green Reload (ER60G); ETHICON 3D 60mm Black Reload (ER60T) | GDW | Substantially Equivalent | |
| K243276 | ECHELON LINEAR™ Stapler 30mm Stapler (GTX30); ECHELON LINEAR™ Stapler 60mm Stapler (GTX60); ECHELON LINEAR™ Stapler 90mm Stapler (GTX90); ECHELON LINEAR™ Stapler 3D 30mm Blue Reload (GTXR30B); ECHELON LINEAR™ Stapler 3D 30mm Green Reload (GTXR30G); ECHELON LINEAR™ Stapler 3D 60mm Blue Reload (GTXR60B); ECHELON LINEAR™ Stapler 3D 60mm Green Reload (GTXR60G); ECHELON LINEAR™ Stapler 3D 90mm Blue Reload (GTXR90B); ECHELON LINEAR™ Stapler 3D 90mm Green Reload (GTXR90G) | GDW | Substantially Equivalent | |
| K241630 | ECHELON 4000 60mm Compact Stapler (EC3D60C); ECHELON 4000 60mm Standard Stapler (EC3D60S); ECHELON 4000 60mm Long Stapler (EC3D60L); ECHELON 3D 60mm White Reload (ER60W); ECHELON 3D 60mm Blue Reload (ER60B); ECHELON 3D 60mm Green Reload (ER60G); ECHELON 3D 60mm Black Reload (ER60T) | GDW | Substantially Equivalent | |
| K241629 | ECHELON 3000 45mm Compact Stapler (ECH45C); Echelon 3000 45mm Standard Stapler (ECH45S); Echelon 3000 45mm Long Stapler (ECH45L); Echelon 3000 60mm Compact Stapler (ECH60C); Echelon 3000 60mm Standard Stapler (ECH60S); Echelon 3000 60mm Long Stapler (ECH60L) | GAG | Substantially Equivalent | |
| K232313 | LIGACLIP Endoscopic Rotating Multiple Clip Applier 12mm L (ER420); LIGACLIP Endoscopic Rotating Multiple Clip Applier 10mm M/L (ER320) | FZP | Substantially Equivalent | |
| K230387 | ENSEAL X1 Curved Tissue Sealers, 25 cm shaft length (NSLX125C); ENSEAL X1 Curved Tissue Sealers, 37 cm shaft length (NSLX137C); ENSEAL X1 Curved Tissue Sealers, 45 cm shaft ength (NSLX137C); ENSEAL X1 Straight Tissue Sealers, 25 cm shaft length (NSLX125S); ENSEAL X1 Straight Tissue Sealers, 37 cm shaft length (NSLX137S) | GEI | Substantially Equivalent | |
| K223760 | ECHELON LINEAR™ 60 mm Cutter (GLC60);ECHELON LINEAR™ 80mm Cutter (GLC80);ECHELON LINEAR™ 100 mm Cutter (GLC100);ECHELON LINEAR™ Cutters 60mm Blue Reload (GLCR60B);ECHELON LINEAR™ Cutters 60mm Green Reload (GLCR60G);ECHELON LINEAR™ Cutters 80mm Blue Reload (GLCR80B);ECHELON LINEAR™ Cutters 80mm Green Reload (GLCR80G);ECHELON LINEAR™ Cutters 100mm Blue Reload (GLCR100B);ECHELON LINEAR™ Cutters 100mm Green Reload (GLCR100G) | GDW | Substantially Equivalent | |
| K221790 | HARMONIC 700 Shears | LFL | Substantially Equivalent | |
| K221343 | ECHELON ENDOPATH Staple Line Reinforcement | OXC | Substantially Equivalent | |
| K213633 | ECHELON 3000 45mm Stapler, ECHELON 3000 60mm Stapler | GAG | Substantially Equivalent | |
| K211273 | Harmonic Hand Piece, Blue, Harmonic Hand Piece, Gray | LFL | Substantially Equivalent | |
| K201696 | ENSEAL X1 Tissue Sealer, Straight Jaw, 25 cm Shaft Length, ENSEAL X1 Tissue Sealer, Straight Jaw, 37 cm Shaft Length | GEI | Substantially Equivalent | |
| K201066 | ENSEAL X1 Tissue Sealer, Curved Jaw, 25 cm Shaft Length, ENSEAL X1 Tissue Sealer, Curved Jaw, 37 cm Shaft Length, ENSEAL X1 Tissue Sealer, Curved Jaw, 45 cm Shaft Length | GEI | Substantially Equivalent | |
| K202665 | Echelon Flex 45mm Powered Plus Articulating Endoscopic Linear cutters, Echelon Flex 60mm Powered Plus Articulating Endoscopic Linear cutters, Echelon Endopath Endoscopic Linear Cutter Reloads, 45mm, Echelon Endopath Endoscopic Linear Cutter Reloads, 60mm | GDW | Substantially Equivalent | |
| K201280 | Ethicon Circular Stapler, Ethicon Circular Stapler -XL Sealed | GDW | Substantially Equivalent | |
| K200420 | Echelon Contour Curved Cutter with blue reload, Echelon Contour Curved Cutter with green reload, Echelon Contour Curved Cutter reload, Blue, Echelon Contour Curved Cutter reload, Green | GDW | Substantially Equivalent | |
| K200253 | Megadyne Telescoping Smoke Evacuation Pencil - 10ft tubing, Megadyne Telescoping Smoke Evacuation Pencil - 15ft tubing, Megadyne Telescoping Smoke Evacuation Soft Tissue Dissector, Megadyne Telescoping Soft Tissue Dissector | GEI | Substantially Equivalent | |
| K200841 | Harmonic 1100 Shears, 20cm length, Harmonic 1100 36cm length, Generator G11 | GEI | Substantially Equivalent | |
| K191555 | HARMONIC HD 1000i Shears, 20 cm length, HARMONIC HD 1000i Shears, 36 cm length | LFL | Substantially Equivalent | |
| K190937 | Echelon Endopath Staple Line Reinforcement | OXC | Substantially Equivalent | |
| K183435 | Echelon Endoscopic Linear Cutter Reloads, White, Blue, Gold, Green and Black | GDW | Substantially Equivalent | |
| K181488 | LIGACLIP 12mm L Endoscopic Rotating Multiple Clip Applier | FZP | Substantially Equivalent | |
| K181653 | Ethicon Circular Stapler, Ethicon Circular Stapler -XL Sealed | GDW | Substantially Equivalent | |
| K180403 | ENSEAL X1 Tissue Sealer, Curved Jaw, Articulating 37 cm Shaft Length; ENSEAL X1 Tissue Sealer, Curved Jaw, Articulating 45 cm Shaft Length | GEI | Substantially Equivalent | |
| K180031 | Endopath Electrosurgery Probe Plus II | GEI | Substantially Equivalent | |
| K172580 | ENSEAL X1 Tissue Sealer, Straight Jaw, 25 cm Shaft Length, ENSEAL X1 Tissue Sealer, Straight Jaw, 37 cm Shaft Length, ENSEAL X1 Tissue Sealer, Curved Jaw, 25 cm Shaft Length,ENSEAL X1 Tissue Sealer, Curved Jaw, 37 cm Shaft Length,ENSEAL X1 Tissue Sealer, Curved Jaw, 45 cm Shaft Length | GEI | Substantially Equivalent | |
| K163523 | ECHELON CIRCULAR Powered Stapler | GDW | Substantially Equivalent | |
| K163548 | ENSEAL X1 Large Jaw Tissue Sealer | GEI | Substantially Equivalent | |
| K163454 | ECHELON FLEX 45mm Powered Plus Articulating Endoscopic Linear Cutters, ECHELON ENDOPATH Endoscopic Linear Cutter Reloads, 45mm | GDW | Substantially Equivalent | |
| K160554 | Enseal X1 Large Jaw Tissue Sealer | GEI | Substantially Equivalent | |
| K160128 | Endopath Electrosurgery Probe Plus II | GEI | Substantially Equivalent | |
| K160521 | ECHELON FLEX 60 Powered Plus Compact Articulating Endoscopic Linear Cutter, 280mm | GDW | Substantially Equivalent | |
| K151136 | HARMONIC HOOK | LFL | Substantially Equivalent | |
| K150840 | Ligaclip 10mm M/L Endoscopic Rotating Multiple Clip Applier | FZP | Substantially Equivalent | |
| K151340 | HARMONIC Focus Long Shears + Adaptive Tissue Technology | LFL | Substantially Equivalent | |
| K150026 | Endopath ETS-Flex45 Endoscopic Articulating Linear Cutter, Endopath ETS-Flex45 No-Knife Articulating Linear Stapler | GDW | Substantially Equivalent | |
| K141952 | ECHELON FLEX POWERED VASCULAR STAPLER WITH ADVANCED PLACEMENT TIP, ENDOPATH ECHELON VASCULAR WHITE RELOADS FOR ADVANCED | GDW | Substantially Equivalent | |
| K141122 | HARMONIC SCALLOP BLADE, GENERATOR G11 | GEI | Substantially Equivalent | |
| K140560 | ECHELON FLEX POWERED PLUS ARTICULATING ENDOSCOPIC LINEAR CUTTER, 60MM, STANDARD, ECHELON FLEX POWERED PLUS ARTICULATING | GDW | Substantially Equivalent | |
| K132522 | HARMONIC ACE CURVED SHEARS WITH ERGONOMIC HANDLE | LFL | Substantially Equivalent | |
| K133314 | HARMONIC FOCUS SHEARS + ADAPTIVE TISSUE TECHNOLOGY | LFL | Substantially Equivalent | |
| K132512 | HARMONIC ACE CURVED SHEARS WITH SCISSOR HANDLE, HARMONIC ACE CURVED SHEARS WITH ERGONOMIC HANDLE | LFL | Substantially Equivalent | |
| K131663 | ECHELON ENDOSCOPIC LINEAR CUTTER RELOAD, BLACK | GDW | Substantially Equivalent | |
| K132612 | HARMONIC ACE+ SHEARS 23 CM LENGTH WITH ADVANCED HEMOSTASIS, HARMONIC ACE + LAPAROSCOPIC SHEARS 36 CM LENGTH WITH ADVANCE | LFL | Substantially Equivalent | |
| K131435 | ENSEAL G2 TISSUE SEALER, STRAIGHT JAW, ENSEAL G2 TISSUE SEALER, CURVED JAW, ENSEAL TRIO TISSUE SEALER, 3 MM CURVED JAW, | GEI | Substantially Equivalent | |
| K130653 | ECHELON FLEX 45 POWERED ARTICULATING ENDOSCOPIC LINEAR CUTTER; ECHELON FLEX 60 POWERED ARTICULATING ENDOSCOPIC LINEAR CU | GDW | Substantially Equivalent | |
| K123212 | ETHICON ENDO-SURGERY ENSEAL G2 CORDLESS TISSUE SEALERS | PDG | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 1527736 | 1527736 | ETHICON ENDO-SURGERY, INC. | 4545 CREEK RD., Cincinnati, OH 45242 US | 2026 | and 10 more, listed in full below |
| 3005075853 | 3005075853 | ETHICON ENDO-SURGERY, LLC | 475 CALLE C, GUAYNABO, PR 00969 US | 2026 | and 8 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- FERAnoscope And Accessories
- FYDApparatus, Exhaust, Surgical
- FDPApparatus, Pneumoperitoneum, Automatic
- KCJApplicator, Ent
- HBTApplier, Hemostatic Clip
- GDOApplier, Surgical, Clip
- GEACannula, Surgical, General & Plastic Surgery
- GBZCatheter, Cholangiography
- FOZCatheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
- FZPClip, Implantable
- KNQDilator, Esophageal
- GDIDissector, Surgical, General & Plastic Surgery
- HGIElectrocautery, Gynecologic (And Accessories)
- PDGElectrosurgical Vessel And/Or Tissue Sealer. With Built-In Generator.
- GEIElectrosurgical, Cutting & Coagulation & Accessories
- ODCEndoscope Channel Accessory
- GCMEndoscope, Rigid
- OCWEndoscopic Tissue Approximation Device
- KNWInstrument, Biopsy
- MDMInstrument, Manual, Surgical, General Use
- LFLInstrument, Ultrasonic Surgical
- HIFInsufflator, Laparoscopic
- GCJLaparoscope, General & Plastic Surgery
- HETLaparoscope, Gynecologic (And Accessories)
- QJNLaparoscopic Accessories, Esophageal Sizing
- FQHLavage, Jet
- MNDLigator, Esophageal
- NEUMarker, Radiographic, Implantable
- OXCMesh, Surgical, Absorbable, Staple Line Reinforcement
- OXTPercutaneous Surgical Set With Attachments
- LZAPolymer Patient Examination Glove
- GEXPowered Laser Surgical Instrument
- FDISnare, Flexible
- GDWStaple, Implantable
- GDTStaple, Removable (Skin)
- GAGStapler, Surgical
- GALSuture, Absorbable, Natural
- LRPTray, Surgical
- KNSUnit, Electrosurgical, Endoscopic (With Or Without Accessories)
Recall records
Showing 25 of 178| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0147-2026 | ECHELON LINEAR Cutters Reload 80 mm Blue, intended for transection, resection, and/or creation of anastomoses, Product Number GLC80 | The devices were shipped unsterilized. | Class II | Open, Classified | |
| Z-1746-2025 | Endopath Echelon Vascular White Reload for Advanced Placement Tip (35mm, 4 row); Product code VASECR35 | Firm has received an increase in reports regarding inadvertent instrument lockout during surgical procedures involving the device. If lockout occurs, the device will momentarily activate but will not cut or staple tissue, and additional steps will be required to open it and remove it from tissue. If user is unable to remove the device from the tissue, potential harms to patient include surgical delay, bleeding/hemorrhage, life threatening hemorrhage/hemorrhagic shock, and conversion to open therapy. Two adverse events received, including one patient death. | Class I | Open, Classified | |
| Z-1516-2025 | ETHIBOND EXCEL GRN 36IN(90CM) USP2-0(M3) D/A MH | Identified curing issues with the silicone during the needles manufacturing process. | Class II | Open, Classified | |
| Z-1515-2025 | PROLENE BLU 18IN(45CM) USP6-0(M0.7) S/A P-1 PRM | Identified curing issues with the silicone during the needles manufacturing process. | Class II | Open, Classified | |
| Z-1514-2025 | PDSIIVIO30IN(75CM)USP6-0(M0.7)D/AC-1 | Identified curing issues with the silicone during the needles manufacturing process. | Class II | Open, Classified | |
| Z-1513-2025 | PDSPLUSVIO30IN(75CM)USP6-0(M0.7)D/AC-1MP | Identified curing issues with the silicone during the needles manufacturing process. | Class II | Open, Classified | |
| Z-0834-2024 | ENDOPATH ECHELON 45mm RELOADS WITH GRIPPING SURFACE TECHNOLOGY (GST), ECHELON Endopath Stapler, Endoscopic Linear Cutter Reload (+Gripping Surface technology), 45MM WHITE VASCULAR/THIN, Product No. GST45W | There is the potential for incomplete staple line formation during the firing sequence, without most or all staples, which may lead to insufficient tissue apposition that could require surgical intervention. This may result in bleeding, prolonged surgery, or surgical delay. | Class II | Open, Classified | |
| Z-2356-2021 | HARMONICHD 1000i Shears (36cm Shaft Length)-indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. Product Code: HARHD36 | An internal component may be cracked and become lodged behind the energy button potentially resulting in continuous activation of the device, may result in burns | Class II | Open, Classified | |
| Z-2355-2021 | HARMONIC HD 1000i Shears (20cm Shaft Length)-indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. Product Code: HARHD20 | An internal component may be cracked and become lodged behind the energy button potentially resulting in continuous activation of the device, may result in burns | Class II | Open, Classified | |
| Z-2326-2021 | ECHELON FLEX Powered Plus Stapler-intended for transection, resection, and/or creation of anastomoses. The instruments have application in multiple open or minimally invasive general, gynecologic, urologic, thoracic, and pediatric surgical procedures. Product Code: PSEE60A | Mislabeled: Labeled on the package as 60mm contains 45mm devices | Class II | Terminated | |
| Z-0656-2020 | Ligamax 5 mm Endoscopic Multiple Clip Applier | A potential exists that certain LIGAMAX devices within the impacted lots may have small holes in the Tyvek lidding which could result in a breach of sterility. | Class II | Terminated | |
| Z-0203-2020 | ECHELON FLEX Powered Plus ENDOPATH 60mm Stapler - 340mm shaft, Product Code PSEE60A | The staplers may contain an out of specification anvil component within the jaw of the device. This condition may lead to malformed staples, which can compromise staple line integrity. If the staple line is compromised, there is a potential risk of prolonged surgery, postoperative anastomotic leak, hemorrhage, hemorrhagic shock, additional surgical intervention, or death. | Class I | Terminated | |
| Z-0202-2020 | ECHELON FLEX Powered Plus ENDOPATH 60mm Stapler - 440mm shaft, Product Code PLEE60A | The staplers may contain an out of specification anvil component within the jaw of the device. This condition may lead to malformed staples, which can compromise staple line integrity. If the staple line is compromised, there is a potential risk of prolonged surgery, postoperative anastomotic leak, hemorrhage, hemorrhagic shock, additional surgical intervention, or death. | Class I | Terminated | |
| Z-0201-2020 | ECHELON FLEX Powered Plus ENDOPATH 60mm Stapler - 280mm shaft, Product Code PCEE60A | The staplers may contain an out of specification anvil component within the jaw of the device. This condition may lead to malformed staples, which can compromise staple line integrity. If the staple line is compromised, there is a potential risk of prolonged surgery, postoperative anastomotic leak, hemorrhage, hemorrhagic shock, additional surgical intervention, or death. | Class I | Terminated | |
| Z-0200-2020 | ECHELON FLEX ENDOPATH 60mm Stapler - 340mm shaft, Product Code EC60A | The staplers may contain an out of specification anvil component within the jaw of the device. This condition may lead to malformed staples, which can compromise staple line integrity. If the staple line is compromised, there is a potential risk of prolonged surgery, postoperative anastomotic leak, hemorrhage, hemorrhagic shock, additional surgical intervention, or death. | Class I | Terminated | |
| Z-1890-2019 | Ethicon ENSEAL X1 Curved Jaw Tissue Sealer 45cm Shaft PRODUCT CODE: NSLX145C | Observed reported incidence rate for harm associated with intraoperative bleeding | Class II | Terminated | |
| Z-1889-2019 | Ethicon ENSEAL X1 Curved Jaw Tissue Sealer 37cm Shaft PRODUCT CODE: NSLX137C | Observed reported incidence rate for harm associated with intraoperative bleeding | Class II | Terminated | |
| Z-1888-2019 | Ethicon ENSEAL X1 Curved Jaw Tissue Sealer 25cm Shaft PRODUCT CODE: NSLX125C | Observed reported incidence rate for harm associated with intraoperative bleeding | Class II | Terminated | |
| Z-1278-2019 | Straight Intraluminal Staplers, 33 mm diameter, Model SDH33A The Ethicon Endo-Surgery Intraluminal Staplers (ILS) are anastomotic staplers available in four sizes to permit proper matching of instrument to diameter of the lumen. The instrument permits tissue attachment to the anvil shaft in a location remote from the main body of the instrument to improve access and visibility. | The staplers may have an insufficient firing stroke to break the washer and completely form staples. | Class I | Completed | |
| Z-1277-2019 | Straight Intraluminal Staplers, 29 mm diameter, Model SDH29A The Ethicon Endo-Surgery Intraluminal Staplers (ILS) are anastomotic staplers available in four sizes to permit proper matching of instrument to diameter of the lumen. The instrument permits tissue attachment to the anvil shaft in a location remote from the main body of the instrument to improve access and visibility. | The staplers may have an insufficient firing stroke to break the washer and completely form staples. | Class I | Completed | |
| Z-1276-2019 | Straight Intraluminal Staplers, 25 mm diameter, Model SDH25A The Ethicon Endo-Surgery Intraluminal Staplers (ILS) are anastomotic staplers available in four sizes to permit proper matching of instrument to diameter of the lumen. The instrument permits tissue attachment to the anvil shaft in a location remote from the main body of the instrument to improve access and visibility. | The staplers may have an insufficient firing stroke to break the washer and completely form staples. | Class I | Completed | |
| Z-1275-2019 | Straight Intraluminal Staplers, 21 mm diameter, Model SDH21A The Ethicon Endo-Surgery Intraluminal Staplers (ILS) are anastomotic staplers available in four sizes to permit proper matching of instrument to diameter of the lumen. The instrument permits tissue attachment to the anvil shaft in a location remote from the main body of the instrument to improve access and visibility. | The staplers may have an insufficient firing stroke to break the washer and completely form staples. | Class I | Completed | |
| Z-1274-2019 | Endoscopic Curved Intraluminal Stapler, 33 mm diameter, Model ECS33A The Ethicon Endo-Surgery Intraluminal Staplers (ILS) are anastomotic staplers available in four sizes to permit proper matching of instrument to diameter of the lumen. The instrument permits tissue attachment to the anvil shaft in a location remote from the main body of the instrument to improve access and visibility. | The staplers may have an insufficient firing stroke to break the washer and completely form staples. | Class I | Completed | |
| Z-1273-2019 | Endoscopic Curved Intraluminal Stapler, 29 mm diameter, Model ECS29A The Ethicon Endo-Surgery Intraluminal Staplers (ILS) are anastomotic staplers available in four sizes to permit proper matching of instrument to diameter of the lumen. The instrument permits tissue attachment to the anvil shaft in a location remote from the main body of the instrument to improve access and visibility. | The staplers may have an insufficient firing stroke to break the washer and completely form staples. | Class I | Completed | |
| Z-1272-2019 | Endoscopic Curved Intraluminal Stapler, 25 mm diameter, Model ECS25A The Ethicon Endo-Surgery Intraluminal Staplers (ILS) are anastomotic staplers available in four sizes to permit proper matching of instrument to diameter of the lumen. The instrument permits tissue attachment to the anvil shaft in a location remote from the main body of the instrument to improve access and visibility. | The staplers may have an insufficient firing stroke to break the washer and completely form staples. | Class I | Completed |
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Data as of , FDA export datePage updated Source: openFDA, public domain