Wilson-Cook Medical, Inc.
Wilson-Cook Medical, Inc. holds FDA 510(k) medical device clearances, first cleared 1985, most recent 2026, with 23 FDA device recalls on record.
Top product codes for Wilson-Cook Medical, Inc.
- FGE — Gastroenterology, Urology
- KNT — Gastroenterology, Urology
- KNS — Gastroenterology, Urology
- GCA — Gastroenterology, Urology
- FCG — Gastroenterology, Urology
- FDX — Gastroenterology, Urology
- OCY — Gastroenterology, Urology
- FBK — Gastroenterology, Urology
- EOQ — Ear, Nose, Throat
- ESW — General, Plastic Surgery
FDA recalls by Wilson-Cook Medical, Inc.
10 most recent of 23- Z-1812-2026 — Instinct Plus Endoscopic Clipping Device REF: G58010 Rx Only, Sterile EO
- 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.
- Z-1298-2026 — Product Name: Nasal Jejunal Feeding Tube REF: NJFT-10
- Z-0582-2025 — Cook Medical HEMO-7-EU Hemospray Endoscopic Hemostat, REF G24663, 2.8 cm, sterile.
- 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.
- Z-0462-2024 — QUANTUM TTC BILIARY BALLOON DILATOR, REF QBD-8X3, Order Number G22656; used to dilate strictures of the biliary tree
- Z-0463-2024 — QUANTUM TTC BILIARY BALLOON DILATOR, REF QBD-8X3-E, Order Number G22766; used to dilate strictures of the biliary tree
- Z-0458-2024 — QUANTUM TTC BILIARY BALLOON DILATOR, REF QBD-10X3-E, Order Number G22667; used to dilate strictures of the biliary tree
- Z-0459-2024 — QUANTUM TTC BILIARY BALLOON DILATOR, REF QBD-4X3, Order Number G22654; used to dilate strictures of the biliary tree
- Z-0460-2024 — QUANTUM TTC BILIARY BALLOON DILATOR, REF QBD-6X3, Order Number G22655; used to dilate strictures of the biliary tree
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Wilson-Cook Medical, Inc.
1–100 of 125- K253302 — Hemospray Endoscopic Hemostat (HEMO-[X])
- K243568 — Teslatome Bipolar Sphincterotome; Tesla BiCord Active Cord
- K213356 — Entuit PEG, Entuit PEGJ
- K212323 — Instinct Plus Endoscopic Clipping Device
- K201322 — Entuit Nasal Jejunal Feeding Tube
- K200972 — Hemospray Endoscopic Hemostat
- K200247 — Fusion Quattro Extraction Balloon
- K192339 — TeslaTome Bipolar Sphincterotome, Tesla Bipolar Active Cord
- K193344 — Tri-Ex Extraction Balloon with Multiple Sizing
- K192908 — Fusion Cytology Brush, CytoMax II Double Lumen Cytology Brushes
- K191048 — AcuSnare Polypectomy Snare - Duckbill
- K183336 — Entuit PEG, Entuit PEGJ
- K181317 — Fusion Cytology Brush, CytoMax II Double Lumen Cytology Brush
- K182319 — Glo-Tip Spray Catheter
- K182895 — Wilson-Cook Achalasia Balloon
- K182381 — Wilson-Cook Mini Basket
- K173673 — AcuSnare Polypectomy Snare
- K173659 — Howell D.A.S.H Extraction Balloon with Multiple Sizing
- DEN170015 — Hemospray Endoscopic Hemostat
- 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
- K171973 — Captura® Disposable Hot Biopsy Forceps
- 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
- K163377 — Captura Disposable Bronchoscope Biopsy Forceps
- K171573 — Fusion Cytology Brush, CytoMax II Double Lumen Cytology Brush
- K171548 — Cotton Graduated Dilation Catheter, Fusion Biliary Dilation Catheter, Soehendra Biliary Dilation Catheter, Geenen Graduated Dilation Catheter
- K170292 — Tri-Ex Extraction Balloon With Multiple Sizing
- K171596 — ECHO-3-22: Echotip Ultra and EUSN-1, EUSN-3: Echotip Ultrasound Needle
- K171223 — Quantum TTC Biliary Balloon Dilator
- K160890 — Howell Biliary Introducer Needle
- K162142 — Accessory Irrigation Adapter
- K153763 — Howell Biliary Aspiration Needle
- K160170 — Lehman Manometry Catheter
- K161203 — Soehendra Stent Retriever
- K142950 — Acrobat Calibrated Tip Wire Guide
- K141356 — ECHO TIP ULTRA FIDUCIAL NEEDLE
- K132809 — INSTINCT ENDOSCOPIC HEMOCLIP
- K122816 — AXCESS SOFT TIP WIRE GUIDE
- K111495 — COOK GI ENDOSCOPIC INJECTION GEL KIT, GEL-S, GEL-N, GEL-H, GEL-K
- K101095 — DIRECT PERORAL CHOLANGIOSCOPY BALLOON
- K063677 — FUSION QUATTRO EXTRACTION BALLOON XL
- K052051 — OMNI SPHINCTEROTOME
- K043203 — WILSON-COOK ENTERAL FEEDING TUBE, TIGER TUBE ENTERAL FEEDING TUBE
- K040930 — ZILVER BILIARY STENT SYSTEM USW
- K040800 — WILOSN-COOK BILIARY DILATION BALLOON
- K040324 — WILSON-COOK DOUBLE LUMEN BILIARY CYTOLOGY BRUSH
- K040981 — USW NEEDLEKNIFE PAPILLOTOME
- K040129 — TRI-EX EXTRACTION BALLOON WITH MULTIPLE SIZING
- K040137 — WILSON-COOK USW CAP AND WIRE LOCK
- K040151 — OASIS BILIARY STENT INTRODUCTION SYSTEM
- K033754 — TRACER METRO SMART WIRE GUIDE
- K033203 — WILSON-COOK TRI-TOME SELECT PLUS
- K030618 — WILSON-COOK CELIAC PLEXUS NEUROLYSIS NEEDLE
- K023903 — WILSON-COOK ENDOSCOPIC CLIPPING DEVICE
- K022595 — WILSON-COOK CYSTOTOME
- K011591 — ESOPHAGEAL Z-STENT WITH DUA ANTI-REFLUX VALVE
- K020788 — WILSON-COOK ZILVER BILIARY STENT
- K013356 — WILSON-COOK ULTRASOUND BIOPSY NEEDLE
- K011178 — WILSON-COOK THRU-THE-SCOPE MECHANICAL LITHOTRIPTOR
- K000086 — WILSON-COOK REUSABLE HOT BIOPSY FORCEPS
- K990145 — WILSON-COOK BIPOLAR PROBE
- K990130 — WILSON-COOK PANCREATIC WEDGE STENT
- K984157 — MODIFICATION TO WILSON-COOK LUNG BIOPSY NEEDLE
- K974018 — WILSON-COOK 10 SHOT MULTI-BAND LIGATOR
- K973205 — WILSON-COOK STRICTURE MEASURING CATHETER
- K972674 — WILSON-COOK NEEDLE KNIFE PAPILLOTOME
- K961897 — WILSON-COOK BILIARY INTRODUCER WITH ASPIRATION BIOPSY NEEDLE
- K960415 — WILSON-COOK BALLOON INFLATION DEVICE
- K953951 — WILSON-COOK TRIPLE LUMEN BALLOON STONE EXTRACTOR
- K941350 — WILSON-COOK GIANTURCO-ROSCH Z-STENT AND INTRODUCER
- K935094 — BALLOON DILATION CATHETER
- K944220 — WILSON COOK MULTIPLE BAND LIGATOR
- K933845 — WILSON-COOK BALLOON INFLATION DEVICE
- K920579 — LOW PROFILE PASSPORT PUSH & PULL KITS & PEG TUBE
- K941305 — WILSON-COOK VARIABLE LENGTH GI INJECTION NEEDLE
- K936168 — WILSON-COOK BALLOON INFLATION DEVICE
- K920218 — ESOPHAGEAL Z-STENT
- K934356 — WILSON-COOK GI ASPIRATION NEEDLE
- K932205 — ERCP CATHETER, HYDROPHILIC COATED
- K920703 — GASTROINTESTINAL FEEDING TUBE
- K923470 — DISPOSABLE HOT BIOPSY FORCEPS
- K911588 — BRANDT ESOPHAGEAL CYTOLOGY BALLOON
- K923847 — DISPOSABLE BRONCHOSCOPE BIOPSY FORCEPS
- K900623 — ZIMMON ESOPHAGO-GASTRIC BALLOON TAMPONADE DEVICE
- K912047 — WILSON-COOK RUSSELL GASTROSTOMY KIT
- K910656 — WILSON-COOK DISPOSABLE BIOPSY FORCEPS
- K910497 — WILSON COOK WIRE GUIDE AND PROTECTIVE GUIDE
- K901125 — PROVOCATIVE SENSITIVITY BALLOON
- K904472 — GLASSMAN STONE EXTRACTION SET
- K900924 — WILSON-COOK BALLOON DILATION CATHETERS
- K901163 — WILSON-COOK PULL THROUGH PEG KIT
- K902099 — WILSON-COOK VARICES TAMPONADE BALLOON CUFF
- K900923 — ZIMMON ENDOSCOPIC PANCREATIC STENT
- K903420 — SOEHENDRA STENT RETRIEVER
- K903668 — WILSON-COOK ASPIRATION HANDLE
- K901348 — WILSON-COOK BRONCHOSCOPE BIOPSY FORCEPS
- K902400 — WILSON-COOK RETRIEVAL & GRASPING FORCEPS
- K900058 — WILSON-COOK BILIARY MOTILITY CATHETER
- K902170 — SOEHENDRA LITHOTRIPSY SET
- K900239 — WILSON-COOK ESOPHAGEAL MOTILITY CATHETER
- K902107 — WILSON-COOK SYRINGE HOLDERS
Data sourced from openFDA. This site is unofficial and independent of the FDA.