Wilson-Cook Medical Inc.
Winston Salem, NC, US
Wilson-Cook Medical Inc. appears in FDA device records in Winston Salem, NC. FDA records list 131 510(k) clearances between and , one PMA record and one registered establishment. As of , FDA records show 60 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
FDA records under these names
1 nameFDA records resolved to Wilson-Cook Medical 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.
- Cook Endoscopy510(k), PMA, recall
510(k) clearance history
Showing 50 of 131FDA records hold 131 510(k) clearances for Wilson-Cook Medical Inc. between 1985 and 2026. The busiest year on record is 1990, with 21. The most recent is 2026, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1985 | 11 |
| 1987 | 3 |
| 1988 | 1 |
| 1989 | 2 |
| 1990 | 21 |
| 1991 | 5 |
| 1992 | 2 |
| 1993 | 2 |
| 1994 | 7 |
| 1995 | 4 |
| 1996 | 1 |
| 1997 | 3 |
| 1998 | 2 |
| 1999 | 2 |
| 2000 | 1 |
| 2001 | 2 |
| 2002 | 3 |
| 2003 | 4 |
| 2004 | 7 |
| 2005 | 2 |
| 2006 | 1 |
| 2007 | 1 |
| 2009 | 2 |
| 2010 | 1 |
| 2011 | 1 |
| 2012 | 1 |
| 2013 | 1 |
| 2014 | 2 |
| 2016 | 2 |
| 2017 | 8 |
| 2018 | 8 |
| 2019 | 7 |
| 2020 | 5 |
| 2021 | 1 |
| 2022 | 2 |
| 2025 | 2 |
| 2026 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K253302 | Hemospray Endoscopic Hemostat (HEMO-[X]) | QAU | Substantially Equivalent | |
| K251104 | SureTome™ SW Sphincterotome with DomeTip | KNS | Substantially Equivalent | |
| K243568 | Teslatome Bipolar Sphincterotome; Tesla BiCord Active Cord | KNS | Substantially Equivalent | |
| K213483 | SnapLoc Wire Lock | ODC | Substantially Equivalent | |
| K213356 | Entuit PEG, Entuit PEGJ | PIF | Unknown | |
| K212323 | Instinct Plus Endoscopic Clipping Device | PKL | Substantially Equivalent | |
| K201322 | Entuit Nasal Jejunal Feeding Tube | KNT | Unknown | |
| K200972 | Hemospray Endoscopic Hemostat | QAU | Substantially Equivalent | |
| K192697 | Instinct Plus Endoscopic Clipping Device | PKL | Substantially Equivalent | |
| K200247 | Fusion Quattro Extraction Balloon | GCA | Substantially Equivalent | |
| K192339 | TeslaTome Bipolar Sphincterotome, Tesla Bipolar Active Cord | KNS | Substantially Equivalent | |
| K193344 | Tri-Ex Extraction Balloon with Multiple Sizing | GCA | Substantially Equivalent | |
| K192908 | Fusion Cytology Brush, CytoMax II Double Lumen Cytology Brushes | FDX | Substantially Equivalent | |
| K191048 | AcuSnare Polypectomy Snare - Duckbill | FDI | Substantially Equivalent | |
| K183336 | Entuit PEG, Entuit PEGJ | KNT | Unknown | |
| K181317 | Fusion Cytology Brush, CytoMax II Double Lumen Cytology Brush | FDX | Substantially Equivalent | |
| K182319 | Glo-Tip Spray Catheter | OCX | Substantially Equivalent | |
| K182895 | Wilson-Cook Achalasia Balloon | PID | Substantially Equivalent | |
| K182381 | Wilson-Cook Mini Basket | LQR | Substantially Equivalent | |
| K173673 | AcuSnare Polypectomy Snare | FDI | Substantially Equivalent | |
| K173659 | Howell D.A.S.H Extraction Balloon with Multiple Sizing | GCA | Substantially Equivalent | |
| DEN170015 | Hemospray Endoscopic Hemostat | QAU | Unknown | |
| K171969 | Web II Memory Extraction Basket or Memory II Double Lumen Extraction Basket, Memory 5 Fr. Soft Wire Baskets or Memory Helical Stone Extractor, Memory Eight Wire Baskets or Memory Hard Wire Baskets, Fusion Wire Guided Extraction Basket, Non-Lithotripsy Extraction Basket | LQR | Substantially Equivalent | |
| K171973 | Captura® Disposable Hot Biopsy Forceps | KGE | Substantially Equivalent | |
| K171989 | Classic ERCP Catheter and Huibregtse-Katon ERCP Catheter and Huibregtse-Katon Angled, Glo-Tip ERCP Catheter, Glo-Tip II Double Lumen ERCP Catheter & w/ Radiopaque Bands, Fusion ERCP Catheter with DomeTip and Fusion OMNI ERCP Catheter with DomeTip, Haber RAMP Catheter, Soehendra Universal Catheter | ODD | Substantially Equivalent | |
| K163377 | Captura Disposable Bronchoscope Biopsy Forceps | EOQ | Substantially Equivalent | |
| K171573 | Fusion Cytology Brush, CytoMax II Double Lumen Cytology Brush | FDX | Substantially Equivalent | |
| K171548 | Cotton Graduated Dilation Catheter, Fusion Biliary Dilation Catheter, Soehendra Biliary Dilation Catheter, Geenen Graduated Dilation Catheter | FGE | Substantially Equivalent | |
| K170292 | Tri-Ex Extraction Balloon With Multiple Sizing | GCA | Substantially Equivalent | |
| K171596 | ECHO-3-22: Echotip Ultra and EUSN-1, EUSN-3: Echotip Ultrasound Needle | FCG | Substantially Equivalent | |
| K171223 | Quantum TTC Biliary Balloon Dilator | FGE | Substantially Equivalent | |
| K160890 | Howell Biliary Introducer Needle | FCG | Substantially Equivalent | |
| K162142 | Accessory Irrigation Adapter | ODC | Substantially Equivalent | |
| K153763 | Howell Biliary Aspiration Needle | FCK | Substantially Equivalent | |
| K160170 | Lehman Manometry Catheter | FFX | Substantially Equivalent | |
| K161203 | Soehendra Stent Retriever | FGE | Substantially Equivalent | |
| K142950 | Acrobat Calibrated Tip Wire Guide | OCY | Substantially Equivalent | |
| K141356 | ECHO TIP ULTRA FIDUCIAL NEEDLE | NEU | Substantially Equivalent | |
| K132809 | INSTINCT ENDOSCOPIC HEMOCLIP | PKL | Substantially Equivalent | |
| K122816 | AXCESS SOFT TIP WIRE GUIDE | OCY | Substantially Equivalent | |
| K111495 | COOK GI ENDOSCOPIC INJECTION GEL KIT, GEL-S, GEL-N, GEL-H, GEL-K | FBK | Substantially Equivalent | |
| K101095 | DIRECT PERORAL CHOLANGIOSCOPY BALLOON | FGE | Substantially Equivalent | |
| K090183 | HERCULES 3 STAGE WIRE GUIDED DILATION BALLOON | KNQ | Substantially Equivalent | |
| K083330 | ECHOTIP ULTRA ULTRASOUND NEEDLE | FCG | Substantially Equivalent | |
| K063677 | FUSION QUATTRO EXTRACTION BALLOON XL | GCA | Substantially Equivalent | |
| K061937 | COOK ENDOSCOPY ESOPHAGEAL DILATION BALLOON | KNQ | Substantially Equivalent | |
| K052051 | OMNI SPHINCTEROTOME | KNS | Substantially Equivalent | |
| K043203 | WILSON-COOK ENTERAL FEEDING TUBE, TIGER TUBE ENTERAL FEEDING TUBE | KNT | Substantially Equivalent | |
| K040930 | ZILVER BILIARY STENT SYSTEM USW | FGE | Unknown | |
| K040800 | WILOSN-COOK BILIARY DILATION BALLOON | FGE | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 1037905 | 1037905 | Wilson-Cook Medical Inc. | 4900 Bethania Station Rd, Winston Salem, NC 27105 US | 2026 | and 15 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- GCEAdaptor, Catheter
- GCABiliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection
- FCGBiopsy Needle
- EOQBronchoscope (Flexible Or Rigid)
- GBXCatheter, Irrigation
- FDFColonoscope And Accessories, Flexible/Rigid
- KNQDilator, Esophageal
- FFLDislodger, Stone, Basket, Ureteral, Metal
- LQRDislodger, Stone, Biliary
- ODCEndoscope Channel Accessory
- FDXEndoscopic Cytology Brush
- OCZEndoscopic Grasping/Cutting Instrument, Non-Powered
- PTSEndoscopic Grasping/Cutting Instrument, Non-Powered, Exempt
- OCYEndoscopic Guidewire, Gastroenterology-Urology
- FBKEndoscopic Injection Needle, Gastroenterology-Urology
- OCXEndoscopic Irrigation/Suction System
- ODDEndoscopic Retrograde Cholangiopancreatography (Ercp) Cannula
- PIDEsophageal Dilator Balloon With Or Without Electrode Sensors
- EOXEsophagoscope (Flexible Or Rigid)
- KGEForceps, Biopsy, Electric
- PIFGastrointestinal Tubes With Enteral Specific Connectors
- QAUHemostatic Device For Endoscopic Gastrointestinal Use
- PKLHemostatic Metal Clip For The Gi Tract
- EGQInjector, Jet, Gas-Powered
- KNWInstrument, Biopsy
- FCKInstrument, Biopsy, Suction
- MNDLigator, Esophageal
- FHNLigator, Hemorrhoidal
- LQCLithotriptor, Biliary Mechanical
- NEUMarker, Radiographic, Implantable
- KLAMonitor, Esophageal Motility, Anorectal Motility, And Tube
- GAANeedle, Aspiration And Injection, Disposable
- BSPNeedle, Conduction, Anesthetic (W/Wo Introducer)
- ESWProsthesis, Esophageal
- JCQProsthesis, Esophagus
- FDISnare, Flexible
- FLCStation, Dialysis Control, Negative Pressure Type
- FGEStents, Drains And Dilators For The Biliary Ducts
- FFXSystem, Gastrointestinal Motility (Electrical)
- MVGSystem, Laser, Fiber Optic, Photodynamic Therapy
- FEGTube, Double Lumen For Intestinal Decompression And/Or Intubation
- FPDTube, Feeding
- KNTTubes, Gastrointestinal (And Accessories)
- KNSUnit, Electrosurgical, Endoscopic (With Or Without Accessories)
Recall records
Showing 25 of 60| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1812-2026 | Instinct Plus Endoscopic Clipping Device REF: G58010 Rx Only, Sterile EO | Due to increased in complaints their is the potential for endoscopic clipping device to malfunction. | Class II | Open, Classified | |
| Z-1362-2026 | Teslatome Bipolar Sphincterotomes REF: TESLA-B2535-260 Model Number: G60784 UDI-DI code: 00827002607842 REF: TESLA-B2535-450 Model Number: G60785 UDI-DI code: 00827002607859 These devices are used for cannulation of the ductal system and for sphincterotomy. If preloaded, the device also aids in bridging difficult strictures during ERCP. It is indicated for sphincterotome-aided, wire-guided selective cannulation of the biliary ducts. | Due to product that may contain a void in the material that separates the wire guide and cutting wire lumens, which may cause an inappropriate path of current during cutting. | Class II | Open, Classified | |
| Z-1298-2026 | Product Name: Nasal Jejunal Feeding Tube REF: NJFT-10 | Nasal feeding tube packaged without the nasal transfer tube component. | Class II | Open, Classified | |
| Z-0582-2025 | Cook Medical HEMO-7-EU Hemospray Endoscopic Hemostat, REF G24663, 2.8 cm, sterile. | Specific lots of product have been manufactured with nonconforming raw materials resulting in the red activation knob cracking or breaking at the activation knob internal threading while the device is activated. | Class II | Open, Classified | |
| Z-0036-2025 | Cook Medical Hemo-7 Hemospray Endoscopic Hemostat, REF G56572, 2.8 mm, Sterile; and Hemo-10 Hemospray Endoscopic Hemostat, REF G21049, 3.7 mm, Sterile. The device is used for hemostasis of nonvariceal gastrointestinal bleeding. | Specific lots of product have been manufactured with nonconforming raw materials. | Class II | Open, Classified | |
| Z-0463-2024 | QUANTUM TTC BILIARY BALLOON DILATOR, REF QBD-8X3-E, Order Number G22766; used to dilate strictures of the biliary tree | Nonconforming devices while manufactured correctly, do not comply to their design requirements. Potential harms associated with balloon detachment are endoscopic retrieval of an impacted or non-impacted object, bleeding caused by the retrieval device, or the incident can occur without injury and the object is left to pass naturally. | Class II | Open, Classified | |
| Z-0462-2024 | QUANTUM TTC BILIARY BALLOON DILATOR, REF QBD-8X3, Order Number G22656; used to dilate strictures of the biliary tree | Nonconforming devices while manufactured correctly, do not comply to their design requirements. Potential harms associated with balloon detachment are endoscopic retrieval of an impacted or non-impacted object, bleeding caused by the retrieval device, or the incident can occur without injury and the object is left to pass naturally. | Class II | Open, Classified | |
| Z-0461-2024 | QUANTUM TTC BILIARY BALLOON DILATOR, REF QBD-6X3-E, Order Number G22765; used to dilate strictures of the biliary tree | Nonconforming devices while manufactured correctly, do not comply to their design requirements. Potential harms associated with balloon detachment are endoscopic retrieval of an impacted or non-impacted object, bleeding caused by the retrieval device, or the incident can occur without injury and the object is left to pass naturally. | Class II | Open, Classified | |
| Z-0460-2024 | QUANTUM TTC BILIARY BALLOON DILATOR, REF QBD-6X3, Order Number G22655; used to dilate strictures of the biliary tree | Nonconforming devices while manufactured correctly, do not comply to their design requirements. Potential harms associated with balloon detachment are endoscopic retrieval of an impacted or non-impacted object, bleeding caused by the retrieval device, or the incident can occur without injury and the object is left to pass naturally. | Class II | Open, Classified | |
| Z-0459-2024 | QUANTUM TTC BILIARY BALLOON DILATOR, REF QBD-4X3, Order Number G22654; used to dilate strictures of the biliary tree | Nonconforming devices while manufactured correctly, do not comply to their design requirements. Potential harms associated with balloon detachment are endoscopic retrieval of an impacted or non-impacted object, bleeding caused by the retrieval device, or the incident can occur without injury and the object is left to pass naturally. | Class II | Open, Classified | |
| Z-0458-2024 | QUANTUM TTC BILIARY BALLOON DILATOR, REF QBD-10X3-E, Order Number G22667; used to dilate strictures of the biliary tree | Nonconforming devices while manufactured correctly, do not comply to their design requirements. Potential harms associated with balloon detachment are endoscopic retrieval of an impacted or non-impacted object, bleeding caused by the retrieval device, or the incident can occur without injury and the object is left to pass naturally. | Class II | Open, Classified | |
| Z-0457-2024 | QUANTUM TTC BILIARY BALLOON DILATOR, REF QBD-10X3, Order Number G22657; used to dilate strictures of the biliary tree | Nonconforming devices while manufactured correctly, do not comply to their design requirements. Potential harms associated with balloon detachment are endoscopic retrieval of an impacted or non-impacted object, bleeding caused by the retrieval device, or the incident can occur without injury and the object is left to pass naturally. | Class II | Open, Classified | |
| Z-2253-2023 | Fusion Lithotripsy Extraction Basket, Model Number FS-LXB-3X6 G48278; Fusion Lithotripsy Extraction Baskets are intended to be used for endoscopic removal of biliary stones and foreign bodies. | Non-conforming product may appear in the field as inability to advance or retract the basket, or the drive wire breaking or separating from handle (with or without mechanical lithotripsy). | Class II | Open, Classified | |
| Z-2252-2023 | Fusion Lithotripsy Extraction Basket, Model Number FS-LXB-2X4 G48277; Fusion Lithotripsy Extraction Baskets are intended to be used for endoscopic removal of biliary stones and foreign bodies. | Non-conforming product may appear in the field as inability to advance or retract the basket, or the drive wire breaking or separating from handle (with or without mechanical lithotripsy). | Class II | Open, Classified | |
| Z-1979-2023 | Hemospray Endoscopic Hemostat: Reference Part Numbers: a) HEMO-10, REF G21049; b) HEMO-10-EU, REF G21346 | There are potential risks of the Hemospray powder adhering to the distal end of the endoscope, which can result in adhesion of the endoscope to tissue and consequent difficulty or inability to maneuver/remove the endoscope. | Class II | Open, Classified | |
| Z-1978-2023 | Hemospray Endoscopic Hemostat: Reference Part Numbers: a) HEMO-7, REF G56572; b) HEMO-7-EU, REF G24663; | There are potential risks of the Hemospray powder adhering to the distal end of the endoscope, which can result in adhesion of the endoscope to tissue and consequent difficulty or inability to maneuver/remove the endoscope. | Class II | Open, Classified | |
| Z-1746-2020 | HEMO-10 Hemospray Endoscopic Hemostat | Complaints that the handle and/or activation knob on Hemostat devices have cracked or broken when the device is activated. In some cases, this has caused the carbon dioxide cartridge to exit the handle. Most of these complaints reported that the carbon dioxide cartridge exited the handle with minimal force. However, some complaints reported that the carbon dioxide cartridge exited the handle with the potential to project towards a user or a patient. | Class II | Terminated | |
| Z-1745-2020 | HEMO-7 Hemospray Endoscopic Hemostat | Complaints that the handle and/or activation knob on Hemostat devices have cracked or broken when the device is activated. In some cases, this has caused the carbon dioxide cartridge to exit the handle. Most of these complaints reported that the carbon dioxide cartridge exited the handle with minimal force. However, some complaints reported that the carbon dioxide cartridge exited the handle with the potential to project towards a user or a patient. | Class II | Terminated | |
| Z-2541-2019 | Hemospray Endoscopic Hemostat | Potential for Hemospray device to be unable to spray powder due to misassembly of devices. | Class II | Terminated | |
| Z-2089-2019 | Acuject Variable Injection Needle | Potential for occluded injection needles. | Class II | Terminated | |
| Z-1132-2019 | Acusnare Polypectomy (Duck Bill Shaped) Snare Used with an electrosurgical unit for endoscopic polypectomy. | Complaints of the snare loop not completely retracting and/or misshaping of the snare loop. | Class II | Terminated | |
| Z-0775-2019 | COOK MEDICAL Captura SERRATED LARGE FORCEP-NO SPIKE, 2.4 mm, 230 cm, DBF-2.4SL- 230-20-S | The product is being recalled because Captura Serrated Forceps with Spike (DBF-2.4SN-230SP-20-S) were mislabeled as Captura Serrated Large Forcep-No Spike (DBF-2.4SL-230-20-S) and Captura Serrated Large Forcep-No Spike (DBF-2.4SL-230-20-S) were mislabeled as Captura Serrated Forceps with Spike (DBF-2.4SN-230SP-20-S). | Class II | Terminated | |
| Z-0774-2019 | COOK MEDICAL Captura SERRATED BIOPSY FORCEPS WITH SPIKE,2.4 mm, 230 cm, with Spike, DBF-2.4SN-230SP-20-S | The product is being recalled because Captura Serrated Forceps with Spike (DBF-2.4SN-230SP-20-S) were mislabeled as Captura Serrated Large Forcep-No Spike (DBF-2.4SL-230-20-S) and Captura Serrated Large Forcep-No Spike (DBF-2.4SL-230-20-S) were mislabeled as Captura Serrated Forceps with Spike (DBF-2.4SN-230SP-20-S). | Class II | Terminated | |
| Z-2691-2011 | Disposable Hemostasis Clip, DCH-7-230, Rx only, Single Use only, Cook Medical Product Usage: This device is used for endoscopic clip placement within the gastrointestinal tract for the purpose of endoscopic marking, hemostasis for mucosal sub-mucosal defects less thank 3cm in the upper GI tract, bleeding ulcers, arteries les than 2 mm, and polyps less than 1.5cm in diameter in the GI tract,. This device is not intended for the repair of GI tract luminal perforations. | The disposable clip may not deploy after being positioned inside the patient. | Terminated | ||
| Z-0926-2011 | DPOC-20, Direct Peroral Cholangioscopy Balloon, G54951, 20 mm/17 mL, Rx Only, Cook Medical, Winston-Salem, NC 27105 This device is intended to guide both optical and accessory devices for diagnostic and therapeutic applications during endoscopic procedures in the pancreaticobiliary system including the hepatic ducts. Also, used for endoscopic removal of biliary stones. | There is a risk of gastrointestinal perforation or air embolism due to balloon deflation difficulty, resulting in poor patient outcomes. | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain