Medical Device Manufacturer · US , Winstrom-Salem , NC

Wilson-Cook Medical, Inc.

124 submissions · 117 cleared · Since 1985
124
Total
117
Cleared
1
Denied

Wilson-Cook Medical, Inc. — FDA 510(k) Submissions

Wilson-Cook Medical, Inc. has submitted 124 FDA 510(k) premarket notifications since 1985, of which 117 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Stents, Drains And Dilators For The Biliary Ducts, Tubes, Gastrointestinal (and Accessories), Unit, Electrosurgical, Endoscopic (with Or Without Accessories), Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection, Endoscopic Guidewire, Gastroenterology-urology . Use the specialty filter in the sidebar to narrow results.

124 devices
1–25 of 124
Teslatome Bipolar Sphincterotome; Tesla BiCord Active Cord
K243568 · KNS Unit, Electrosurgical,... · Gastroenterology & Urology
Jan 2025 60d
Entuit PEG, Entuit PEGJ
K213356 · PIF Gastrointestinal Tubes... · Gastroenterology & Urology
Jan 2022 100d
Instinct Plus Endoscopic Clipping Device
K212323 · PKL Hemostatic Metal Clip For... · Gastroenterology & Urology
Aug 2021 30d
Entuit Nasal Jejunal Feeding Tube
K201322 · KNT Tubes, Gastrointestinal... · Gastroenterology & Urology
Jun 2020 30d
Hemospray Endoscopic Hemostat
K200972 · QAU Hemostatic Device For... · General & Plastic Surgery
Jun 2020 58d
Fusion Quattro Extraction Balloon
K200247 · GCA Biliary Catheter For... · Gastroenterology & Urology
Feb 2020 27d
TeslaTome Bipolar Sphincterotome, Tesla Bipolar Active Cord
K192339 · KNS Unit, Electrosurgical,... · Gastroenterology & Urology
Jan 2020 155d
Tri-Ex Extraction Balloon with Multiple Sizing
K193344 · GCA Biliary Catheter For... · Gastroenterology & Urology
Dec 2019 10d
Fusion Cytology Brush, CytoMax II Double Lumen Cytology Brushes
K192908 · FDX Endoscopic Cytology Brush · Gastroenterology & Urology
Nov 2019 30d
AcuSnare Polypectomy Snare - Duckbill
K191048 · FDI Snare, Flexible · Gastroenterology & Urology
Jul 2019 90d
Entuit PEG, Entuit PEGJ
K183336 · KNT Tubes, Gastrointestinal... · Gastroenterology & Urology
May 2019 177d
Fusion Cytology Brush, CytoMax II Double Lumen Cytology Brush
K181317 · FDX Endoscopic Cytology Brush · Gastroenterology & Urology
Feb 2019 266d
Glo-Tip Spray Catheter
K182319 · OCX Endoscopic... · Gastroenterology & Urology
Feb 2019 158d
Wilson-Cook Achalasia Balloon
K182895 · PID Esophageal Dilator... · Gastroenterology & Urology
Jan 2019 102d
Wilson-Cook Mini Basket
K182381 · LQR Dislodger, Stone, Biliary · Gastroenterology & Urology
Oct 2018 60d
AcuSnare Polypectomy Snare
K173673 · FDI Snare, Flexible · Gastroenterology & Urology
Aug 2018 267d
Howell D.A.S.H Extraction Balloon with Multiple Sizing
K173659 · GCA Biliary Catheter For... · Gastroenterology & Urology
Jul 2018 219d
Hemospray Endoscopic Hemostat
DEN170015 · QAU Hemostatic Device For... · General & Plastic Surgery
May 2018 424d
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
K171969 · LQR Dislodger, Stone, Biliary · Gastroenterology & Urology
Mar 2018 271d
Captura? Disposable Hot Biopsy Forceps
K171973 · KGE Forceps, Biopsy, Electric · Gastroenterology & Urology
Mar 2018 264d
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
K171989 · ODD Endoscopic Retrograde... · Gastroenterology & Urology
Mar 2018 260d
Captura Disposable Bronchoscope Biopsy Forceps
K163377 · EOQ Bronchoscope (flexible Or... · Ear, Nose, Throat
Feb 2018 447d
Fusion Cytology Brush, CytoMax II Double Lumen Cytology Brush
K171573 · FDX Endoscopic Cytology Brush · Gastroenterology & Urology
Dec 2017 213d
Cotton Graduated Dilation Catheter, Fusion Biliary Dilation Catheter, Soehendra Biliary Dilation Catheter, Geenen Graduated Dilation Catheter
K171548 · FGE Stents, Drains And... · Gastroenterology & Urology
Oct 2017 140d
Tri-Ex Extraction Balloon With Multiple Sizing
K170292 · GCA Biliary Catheter For... · Gastroenterology & Urology
Sep 2017 232d

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