CooperSurgical, Inc.
Trumbull, CT, US
COOPERSURGICAL, INC. appears in FDA device records in Trumbull, CT. FDA records list 103 510(k) clearances between and , 79 PMA records and 2 registered establishments. As of , FDA records show 128 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
FDA records under these names
6 namesFDA records resolved to CooperSurgical, Inc. carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.
- Apple Medical Corp.510(k), recall
- Cooper Surgical510(k), enforcement report, recall
- Humagen Fertility Diagnostics, Inc.510(k), recall
- ORIGIO HUMAGEN PIPETS INC.recall
- Origio, Inc.registration, 510(k), enforcement report, recall
- Wallach Surgical Devices, Inc.510(k), recall
510(k) clearance history
Showing 50 of 103FDA records hold 103 510(k) clearances for CooperSurgical, Inc. between 1981 and 2026. The busiest year on record is 1999, with 13. The most recent is 2026, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1981 | 2 |
| 1982 | 1 |
| 1985 | 1 |
| 1986 | 1 |
| 1987 | 3 |
| 1988 | 1 |
| 1990 | 1 |
| 1991 | 6 |
| 1992 | 1 |
| 1994 | 4 |
| 1995 | 6 |
| 1996 | 2 |
| 1997 | 6 |
| 1998 | 1 |
| 1999 | 13 |
| 2000 | 3 |
| 2002 | 8 |
| 2003 | 2 |
| 2004 | 1 |
| 2005 | 1 |
| 2006 | 1 |
| 2008 | 1 |
| 2009 | 1 |
| 2010 | 1 |
| 2012 | 1 |
| 2014 | 7 |
| 2015 | 3 |
| 2016 | 3 |
| 2017 | 5 |
| 2018 | 4 |
| 2019 | 4 |
| 2020 | 4 |
| 2022 | 1 |
| 2025 | 2 |
| 2026 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K253698 | Milex™ Incontinence Dish Pessaries; Milex™ Incontinence Dish Pessaries with Support; Milex™ Cube Pessaries; Milex™ Cube Pessaries with Drainage Holes | HHW | Substantially Equivalent | |
| K243799 | Fetal Pillow | PWB | Substantially Equivalent | |
| K250438 | CooperSurgical Milex® Pessaries | HHW | Substantially Equivalent | |
| K223064 | ALLY II Uterine Positioning System™ (UPS) | LKF | Substantially Equivalent | |
| K200815 | VitriGuard | MQK | Substantially Equivalent | |
| K201086 | Advincula Delineator Uterine Manipulator | HEW | Substantially Equivalent | |
| K200038 | Endosee System | HIH | Substantially Equivalent | |
| K191020 | G210 InviCell Plus with SignipHy pH monitoring | PUB | Substantially Equivalent | |
| K191291 | Wallace Dual Lumen Oocyte Recovery System | MQE | Substantially Equivalent | |
| K190639 | Endosee System | HIH | Substantially Equivalent | |
| K182959 | Wallace Dual Lumen Oocyte Recovery System | MQE | Substantially Equivalent | |
| K183020 | Endosee System | HIH | Substantially Equivalent | |
| K180740 | VitriGuard | MQK | Substantially Equivalent | |
| K180429 | Advincula Delineator Uterine Manipulator | HEW | Substantially Equivalent | |
| K173731 | SAGE Vitrification Kit (ART-8025 and ART-8026) / SAGE Vitrification Warming Kit (ART-8030 and ART-8031) | MQL | Substantially Equivalent | |
| K173624 | ORIGIO® Handling™ without phenol red (Cat. No. 8310), ORIGIO® Handling™ with phenol red (Cat. No. 8311) | MQL | Substantially Equivalent | |
| K172197 | SAGE 1-Step GM-CSF with HSA, SAGE 1-Step GM-CSF with SPS | MQL | Substantially Equivalent | |
| K170660 | Endosee Hysteroscope with Disposable Diagnostic (Dx) Cannula | HIH | Substantially Equivalent | |
| K170560 | SAGE Vitrification Kit and SAGE Vitrification Warming Kit | MQL | Substantially Equivalent | |
| K161547 | Transem and EchoGen Embryo Transfer Catheters | MQF | Substantially Equivalent | |
| K162833 | VitriGuard | MQK | Substantially Equivalent | |
| K153267 | ORIGIO Gradient 100, ORIGIO Gradient 90, ORIGIO Gradient 40/80, ORIGIO Sperm Wash | MQL | Substantially Equivalent | |
| K151845 | Infant Heel Warmer (Model 24401) and WarmGel Infant Heel Warmer (Model 20418) | MPO | Substantially Equivalent | |
| K152932 | BlastGen | MQL | Substantially Equivalent | |
| K153092 | Ally Uterine Positioning System | LKF | Substantially Equivalent | |
| K143650 | CooperSurgical Advincula Delineator Uterine Manipulator | HEW | Substantially Equivalent | |
| K143415 | Air Bubble Based Infuser (ABBI) | LKF | Substantially Equivalent | |
| K141523 | ALLY UPS | LKF | Substantially Equivalent | |
| K140754 | COOPER SURGICAL LEISEGANG COLPOSCOPE SYSTEM | HEX | Substantially Equivalent | |
| K140317 | EMBRYOGEN | MQL | Substantially Equivalent | |
| K133912 | ORIGIO SEQUENTIAL FERT, ORIGIO SEQUENTIAL FERT WITH PHENOL RED, ORIGIO SEQUENTIAL CLEAV, ORIGIO SEQUENTIAL CLEAV, ORIGIO | MQL | Substantially Equivalent | |
| K132870 | Origio Gas Line Filter | MQG | Substantially Equivalent | |
| K133387 | ORIGIO(R) SEQUENTIAL BLAST TM; ORIGIO(R) SEQUENTIAL BLAST TM WITH PHENOL RED | MQL | Substantially Equivalent | |
| K133707 | SAGE 1-STEP WITH HUMAN SERUM ALBUMIN, SAGE 1-STEP WITH SERUM PROTEIN SUPPLEMENTS | MQL | Substantially Equivalent | |
| K120136 | EMBRYOGEN | MQL | Substantially Equivalent | |
| K100367 | MEDICULT VITRIFICATION COOLING/WARMING, MODEL REF: 1228, 1229 | MQL | Substantially Equivalent | |
| K091325 | TEN-YEAR FRACTURE RISK OPTION AND SIRI TABLE OPTION FOR NORLAND DXA BONE DENSITOMETERS | KGI | Substantially Equivalent | |
| K063223 | MILEX CONTRACEPTIVE DIAPHRAGM, OMNIFLEX DIAPHRAGMS, ARCING DIAPHRAGMS, WIDESEAL DIAPHRAGMS | HDW | Substantially Equivalent | |
| K061651 | FISCHER CONE BIOPSY EXCISOR, MODELS 900-150, 151, 152, 154, 155, 157 AND 158 | HGI | Substantially Equivalent | |
| K050256 | APPLE MEDICAL/OB MOBIUS ELASTIC RETRACTOR | GAD | Substantially Equivalent | |
| K041131 | APPLE MEDICAL OB MOBIUS ELASTIC RETRACTOR | GCJ | Substantially Equivalent | |
| K021237 | COOPERSURGICAL LAPAROSCOPIC INSTRUMENTS | HET | Substantially Equivalent | |
| K023930 | COOPERSURGICAL OOCYTE RECOVERY NEEDLES | MQE | Substantially Equivalent | |
| K023382 | COOPERSURGICAL MALLEABLE SYTLET | MQF | Substantially Equivalent | |
| K023384 | COOPERSURGICAL TRIAL TRANSFER CATHETER | MQF | Substantially Equivalent | |
| K023383 | COOPERSURGICAL INTRAUTERINE INSEMINATION CATHETER | MQF | Substantially Equivalent | |
| K023379 | COOPERSURGICAL EMBRYO TRANSFER CATHETER, COOPERSURGICAL ASSISTED REPRODUCTION CATHETER | MQF | Substantially Equivalent | |
| K021224 | ENDOCERVICAL BLOCK NEEDLE | HEE | Substantially Equivalent | |
| K020711 | WALLACH LOOP ELECTRODE | GEI | Substantially Equivalent | |
| K014005 | APPLE MEDICAL MOBIUS ELASTIC RETRACTOR | GCJ | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 1216677 | 1216677 | COOPERSURGICAL, INC. | 95 CORPORATE DRIVE, Trumbull, CT 06611 US | 2026 | and 87 more, listed in full below |
| 3004048494 | 3004048494 | ORIGIO A/S | Lautrupvang 2, 1st, Ballerup Hovedstaden 2750 DK | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- HGEAmniotome
- FERAnoscope And Accessories
- GCXApparatus, Suction, Operating-Room, Wall Vacuum Powered
- HFCAspirator, Endocervical
- HFFAspirator, Endometrial
- FAXBougie, Urological
- HFEBrush, Endometrial
- BZCCalculator, Pulmonary Function Data
- HDRCap, Cervical
- BSYCatheters, Suction, Tracheobronchial
- FHAClamp, Penile
- HEXColposcope (And Colpomicroscope)
- FLLContinuous Measurement Thermometer
- HEWCuldoscope (And Accessories)
- HHECup, Menstrual
- HHKCurette, Suction, Endometrial (And Accessories)
- FZSCurette, Surgical, General Use
- HCYCurette, Uterine
- FAJCystoscope And Accessories, Flexible/Rigid
- FENDevice, Cystometric, Hydraulic
- CBHDevice, Fixation, Tracheal Tube
- GXHDevice, Surgical, Cryogenic
- HDWDiaphragm, Contraceptive (And Accessories)
- HDQDilator, Cervical, Fixed Size
- FFPDilator, Rectal
- HGIElectrocautery, Gynecologic (And Accessories)
- GEIElectrosurgical, Cutting & Coagulation & Accessories
- HDBExtractor, Vacuum, Fetal
- DPWFlowmeter, Blood, Cardiovascular
- HFBForceps, Biopsy, Gynecological
- GENForceps, General & Plastic Surgery
- FHQHolder, Needle, Gastroenterologic
- HESInsufflator, Carbon-Dioxide, Uterotubal (And Accessories)
- GCJLaparoscope, General & Plastic Surgery
- HETLaparoscope, Gynecologic (And Accessories)
- FCSLight, Catheter, Fiberoptic, Glass, Ureteral
- HEPMonitor, Blood-Flow, Ultrasonic
- HEKMonitor, Heart Sound, Fetal, Ultrasonic
- GABNeedle, Suturing, Disposable
- HHWPessary, Vaginal
- FHOPneumoperitoneum Needle
- GEXPowered Laser Surgical Instrument
- EMEPunch, Biopsy, Surgical
- GADRetractor
- HDLRetractor, Vaginal
- GDXScalpel, One-Piece
- HDKScissors, Episiotomy
- HEESet, Anesthesia, Paracervical
- HHMSound, Uterine
- HHTSpatula, Cervical, Cytological
- HIBSpeculum, Vaginal, Nonmetal
- GDWStaple, Implantable
- GAHStylet, Surgical, General & Plastic Surgery
- DXNSystem, Measurement, Blood-Pressure, Non-Invasive
- FSMTray, Surgical, Instrument
- DRCTrocar
- FCZTube, Smoke Removal, Endoscopic
- GEHUnit, Cryosurgical, Accessories
- EKZUnit, Electrosurgical, And Accessories, Dental
- BZDVentilator, Non-Continuous (Respirator)
Recall records
Showing 25 of 128| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-2137-2025 | Endosee System Convenience Kit with IV Tube. Model Number: ES-TRAY-IV. Endosee System Convenience Kit with IV Tube. | The HSG Procedure Trays and Endosee System Convenience Kits contain non-sterile iodine pouches, however the peel away lid labels incorrectly identify the iodine pouches as sterile. | Class II | Open, Classified | |
| Z-2136-2025 | Endosee System Convenience Kit. Model Number: ES-TRAY. Endosee System Convenience Kit | The HSG Procedure Trays and Endosee System Convenience Kits contain non-sterile iodine pouches, however the peel away lid labels incorrectly identify the iodine pouches as sterile. | Class II | Open, Classified | |
| Z-2135-2025 | HSG Procedure Tray. Model Number: 6050T. The HSG Procedure Tray is for use in hysterosalpingography and sonohysterography procedures. | The HSG Procedure Trays and Endosee System Convenience Kits contain non-sterile iodine pouches, however the peel away lid labels incorrectly identify the iodine pouches as sterile. | Class II | Open, Classified | |
| Z-0692-2025 | Brand Name: K-Systems Product Name: Multiple/unknown Model/Catalog Number: Multiple/unknown Software Version: N/A Product Description: An electrically-powered device intended to provide suitable warming and/or incubation conditions for reproductive biological materials (e.g., gametes and embryos), at closely regulated and monitored temperatures, during assisted reproduction examination and processing procedures. It may support a more comprehensive growth environment [e.g., temperature, carbon dioxide (CO2) and oxygen (O2) concentration]; it typically has adjustment and monitoring controls. Component: N/A | The warming surfaces or incubator well temperatures of the listed products may exceed the desired set temperature. If temperatures exceed the desired set value, the device will alarm appropriately. | Class II | Open, Classified | |
| Z-0691-2025 | Brand Name: K-Systems Product Name: R65 Trolley Model/Catalog Number: K24012 Software Version: N/A Product Description: An electrically-powered device intended to provide suitable warming and/or incubation conditions for reproductive biological materials (e.g., gametes and embryos), at closely regulated and monitored temperatures, during assisted reproduction examination and processing procedures. It may support a more comprehensive growth environment [e.g., temperature, carbon dioxide (CO2) and oxygen (O2) concentration]; it typically has adjustment and monitoring controls. Component: N/A | The warming surfaces or incubator well temperatures of the listed products may exceed the desired set temperature. If temperatures exceed the desired set value, the device will alarm appropriately. | Class II | Open, Classified | |
| Z-0690-2025 | Brand Name: K-Systems Product Name: T47 Warming Plate Model/Catalog Number: K23055 Software Version: N/A Product Description: An electrically-powered device intended to provide suitable warming and/or incubation conditions for reproductive biological materials (e.g., gametes and embryos), at closely regulated and monitored temperatures, during assisted reproduction examination and processing procedures. It may support a more comprehensive growth environment [e.g., temperature, carbon dioxide (CO2) and oxygen (O2) concentration]; it typically has adjustment and monitoring controls. Component: No | The warming surfaces or incubator well temperatures of the listed products may exceed the desired set temperature. If temperatures exceed the desired set value, the device will alarm appropriately. | Class II | Open, Classified | |
| Z-0689-2025 | Brand Name: K-Systems Product Name: T47 Warming Plate Model/Catalog Number: K23054 Software Version: N/A Product Description: An electrically-powered device intended to provide suitable warming and/or incubation conditions for reproductive biological materials (e.g., gametes and embryos), at closely regulated and monitored temperatures, during assisted reproduction examination and processing procedures. It may support a more comprehensive growth environment [e.g., temperature, carbon dioxide (CO2) and oxygen (O2) concentration]; it typically has adjustment and monitoring controls. Component: No | The warming surfaces or incubator well temperatures of the listed products may exceed the desired set temperature. If temperatures exceed the desired set value, the device will alarm appropriately. | Class II | Open, Classified | |
| Z-0688-2025 | Brand Name: K-Systems Product Name: G85 Mini Incubator Model/Catalog Number: K22074 Software Version: N/A Product Description: An electrically-powered device intended to provide suitable warming and/or incubation conditions for reproductive biological materials (e.g., gametes and embryos), at closely regulated and monitored temperatures, during assisted reproduction examination and processing procedures. It may support a more comprehensive growth environment [e.g., temperature, carbon dioxide (CO2) and oxygen (O2) concentration]; it typically has adjustment and monitoring controls. Component: No | The warming surfaces or incubator well temperatures of the listed products may exceed the desired set temperature. If temperatures exceed the desired set value, the device will alarm appropriately. | Class II | Open, Classified | |
| Z-0687-2025 | Brand Name: K-Systems Product Name: G73 Dry Bath Incubator Model/Catalog Number: K22065 Product Description: An electrically-powered device intended to provide suitable warming and/or incubation conditions for reproductive biological materials (e.g., gametes and embryos), at closely regulated and monitored temperatures, during assisted reproduction examination and processing procedures. It may support a more comprehensive growth environment [e.g., temperature, carbon dioxide (CO2) and oxygen (O2) concentration]; it typically has adjustment and monitoring controls. Component: N/A | The warming surfaces or incubator well temperatures of the listed products may exceed the desired set temperature. If temperatures exceed the desired set value, the device will alarm appropriately. | Class II | Open, Classified | |
| Z-3189-2024 | Stainless Steel Sims Uterine Sound, Part Number 64-601 | During the manufacturing process the devices were laser-marked with the incorrect part number. | Class II | Open, Classified | |
| Z-3188-2024 | Silver-Plated Copper Sims Uterine Sound, Part Number 64-600 | During the manufacturing process the devices were laser-marked with the incorrect part number. | Class II | Open, Classified | |
| Z-3298-2024 | Origio Sperm Wash Medium Pack of Five 60ml bottles - Intended for washing of spermatozoa. Part Number: 84055060D | Low concentration of sodium pyruvate in the wash could compromise gamete development | Class II | Open, Classified | |
| Z-3297-2024 | Origio Sperm Wash Medium Pack of Five 60ml bottles - Intended for washing of spermatozoa. Part Number: 84055060A | Low concentration of sodium pyruvate in the wash could compromise gamete development | Class II | Open, Classified | |
| Z-3296-2024 | Origio Sperm Wash Medium Pack of Ten 10ml bottles - Intended for washing of spermatozoa Part Number: 84051010A | Low concentration of sodium pyruvate in the wash could compromise gamete development | Class II | Open, Classified | |
| Z-1089-2024 | global Medium, Model Numbers LGGG-020 (20mL bottle), LGGG-050 (50mL bottle), LGGG-100 (100mL bottle). Intended use: Culture of human embryos from zygote to blastocyst, embryo transfer. | The firm has become aware of a sudden increase in complaints for three associated lots. Performance issues may lead to impaired embryo development prior to the blastocyst stage. | Class II | Open, Classified | |
| Z-0985-2024 | Box as labeled: Regard, Carter-Thomason CloseSure System XL, REF 733776, Quantity 1 Box of 3 Systems. Kit as labeled: Regard, Carter-Thomason CloseSure System, REF 733776, Contents: One (1) Carter-Thomason Suture Passer, One (1) 5 mm Pilot Guide, One (1) 10/12 mm Pilot Guide. | Incorrect component descriptions within the "Contents" section on the Tyvek lid for individual kit trays. | Class II | Open, Classified | |
| Z-1348-2023 | Global Total LP single step medium, 60mL, bicarbonate-buffered media for D1-5 embryo culture and transfer, Reference Number H5GT-060 | It has come to CooperSurgical's attention that the affected Product may contain a medium other than the Global Total LP single step medium which does not contain the protein source required for embryo culture and development. | Class II | Open, Classified | |
| Z-1044-2023 | BIOPSY MEDIUM 10ML, Reference Number 10620010 A, used for blastomere biopsy of cleavage stage embryos for Pre-implantation Genetic Diagnosis (PGD) | The affected product may contain a medium other than the Biopsy Medium. There is a risk that use of the Product from this lot could cause degradation of the embryo. | Class II | Open, Classified | |
| Z-0223-2023 | NEO-fit Neonatal Endotracheal Tube Grip, Part Number 42-2540 | Firm has received 11 complaints involving a loose or detached metal clips, including 3 cases where the metal clip was ingested by the patient, and 3 cases where the metal clip was removed from the patient's mouth. In one case, the patient suffered a laceration to the throat. | Class II | Open, Classified | |
| Z-1823-2022 | Humidifier bottle and syringe filter kit (6 count of each) for the BT37 Mark II Benchtop Incubator (AY200246) | There is a potential breach to the sterile barrier containing the Humidifier Bottles due to the packaging of the filter box located inside the bottle packaging. Damage to the sterile barrier may result in use of an unsterilized device, which may cause contamination and degradation or loss of embryo during incubation. | Class II | Open, Classified | |
| Z-1822-2022 | Humidifier bottle and syringe filter kit (6 count of each) for the BT37 Mark I Benchtop Incubator (AY102295). The Mark I model is no longer produced, but the legacy humidifier bottle component design can also be used with the BT37 Mark II Benchtop Incubator. | There is a potential breach to the sterile barrier containing the Humidifier Bottles due to the packaging of the filter box located inside the bottle packaging. Damage to the sterile barrier may result in use of an unsterilized device, which may cause contamination and degradation or loss of embryo during incubation. | Class II | Open, Classified | |
| Z-1421-2022 | LifeGlobal Fast Freeze Thawing Kit, Model No. GFT5-055 | There was translation error in the Spanish version of the IFU where the Spanish version instructs the user to leave the blastocyte to air thaw for 5 minutes rather than the correct 5 seconds as indicated in the English version. | Class II | Open, Classified | |
| Z-1108-2022 | VITRIGUARD, CARRIER, CLEAR; Model. No. 43782001 The VitriGuard device is a cryopreservation storage device composed of a stick and cap. | Products in this lot may have compromised barrier seals, introducing a risk to sterility. | Class II | Open, Classified | |
| Z-0504-2024 | CooperSurgical H/S CATHETER SET FR 5 with Integated Stylet Model: 61-4005S For administering contrast media during Hysterosalpingography or Hysterosonography procedures to detect uterine pathology such as polyps, fibroids, adhesions or endometrial thickening, and/or patency of fallopian tubes | Incorrect bonding material used for assembly of the catheter, may fail, resulting in detachment of component parts, broken components, or leakage. This breakage may result in delay of procedure | Class II | Open, Classified | |
| Z-0503-2024 | Cooper Surgical H/S ELLIPTOSPHERE CATH 5 FR Set-For administering contrast media during Hysterosalpingography or Hysterosonography procedures to detect uterine pathology such as polyps, fibroids, adhesions or endometrial thickening, and/or patency of fallopian tubes Model: 61-4005 | Incorrect bonding material used for assembly of the catheter, may fail, resulting in detachment of component parts, broken components, or leakage. This breakage may result in delay of procedure | Class II | Open, Classified |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain