Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Wilson-Cook Medical, Inc. · Predicate Candidate Screening
125 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
88 daysmedian FDA review time
408 days90th percentile
125clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K253302 | Hemospray Endoscopic Hemostat (HEMO-[X]) | Wilson-Cook Medical, Inc. | 2026-06-02 | 246 | 0 |
| K243568 | Teslatome Bipolar Sphincterotome; Tesla BiCord Active Cord | Wilson-Cook Medical, Inc. | 2025-01-17 | 60 | 1 |
| K213356 | Entuit PEG, Entuit PEGJ | Wilson-Cook Medical, Inc. | 2022-01-20 | 100 | 0 |
| K212323 | Instinct Plus Endoscopic Clipping Device | Wilson-Cook Medical, Inc. | 2021-08-25 | 30 | 1 |
| K201322 | Entuit Nasal Jejunal Feeding Tube | Wilson-Cook Medical, Inc. | 2020-06-17 | 30 | 0 |
| K200972 | Hemospray Endoscopic Hemostat | Wilson-Cook Medical, Inc. | 2020-06-10 | 58 | 3 |
| K200247 | Fusion Quattro Extraction Balloon | Wilson-Cook Medical, Inc. | 2020-02-27 | 27 | 0 |
| K192339 | TeslaTome Bipolar Sphincterotome, Tesla Bipolar Active Cord | Wilson-Cook Medical, Inc. | 2020-01-30 | 155 | 0 |
| K193344 | Tri-Ex Extraction Balloon with Multiple Sizing | Wilson-Cook Medical, Inc. | 2019-12-13 | 10 | 0 |
| K192908 | Fusion Cytology Brush, CytoMax II Double Lumen Cytology Brus | Wilson-Cook Medical, Inc. | 2019-11-14 | 30 | 0 |
| K191048 | AcuSnare Polypectomy Snare - Duckbill | Wilson-Cook Medical, Inc. | 2019-07-18 | 90 | 0 |
| K183336 | Entuit PEG, Entuit PEGJ | Wilson-Cook Medical, Inc. | 2019-05-29 | 177 | 0 |
| K181317 | Fusion Cytology Brush, CytoMax II Double Lumen Cytology Brus | Wilson-Cook Medical, Inc. | 2019-02-08 | 266 | 0 |
| K182319 | Glo-Tip Spray Catheter | Wilson-Cook Medical, Inc. | 2019-02-01 | 158 | 0 |
| K182895 | Wilson-Cook Achalasia Balloon | Wilson-Cook Medical, Inc. | 2019-01-25 | 102 | 0 |
| K182381 | Wilson-Cook Mini Basket | Wilson-Cook Medical, Inc. | 2018-10-30 | 60 | 0 |
| K173673 | AcuSnare Polypectomy Snare | Wilson-Cook Medical, Inc. | 2018-08-24 | 267 | 0 |
| K173659 | Howell D.A.S.H Extraction Balloon with Multiple Sizing | Wilson-Cook Medical, Inc. | 2018-07-06 | 219 | 0 |
| DEN170015 | Hemospray Endoscopic Hemostat | Wilson-Cook Medical, Inc. | 2018-05-07 | 424 | 0 |
| K171969 | Web II Memory Extraction Basket or Memory II Double Lumen Ex | Wilson-Cook Medical, Inc. | 2018-03-28 | 271 | 0 |
| K171973 | Captura® Disposable Hot Biopsy Forceps | Wilson-Cook Medical, Inc. | 2018-03-21 | 264 | 0 |
| K171989 | Classic ERCP Catheter and Huibregtse-Katon ERCP Catheter and | Wilson-Cook Medical, Inc. | 2018-03-20 | 260 | 0 |
| K163377 | Captura Disposable Bronchoscope Biopsy Forceps | Wilson-Cook Medical, Inc. | 2018-02-21 | 447 | 0 |
| K171573 | Fusion Cytology Brush, CytoMax II Double Lumen Cytology Brus | Wilson-Cook Medical, Inc. | 2017-12-29 | 213 | 0 |
| K171548 | Cotton Graduated Dilation Catheter, Fusion Biliary Dilation | Wilson-Cook Medical, Inc. | 2017-10-13 | 140 | 0 |
| K170292 | Tri-Ex Extraction Balloon With Multiple Sizing | Wilson-Cook Medical, Inc. | 2017-09-20 | 232 | 0 |
| K171596 | ECHO-3-22: Echotip Ultra and EUSN-1, EUSN-3: Echotip Ultraso | Wilson-Cook Medical, Inc. | 2017-08-04 | 65 | 0 |
| K171223 | Quantum TTC Biliary Balloon Dilator | Wilson-Cook Medical, Inc. | 2017-06-16 | 51 | 7 |
| K160890 | Howell Biliary Introducer Needle | Wilson-Cook Medical, Inc. | 2017-06-14 | 440 | 0 |
| K162142 | Accessory Irrigation Adapter | Wilson-Cook Medical, Inc. | 2017-04-27 | 269 | 0 |
| K153763 | Howell Biliary Aspiration Needle | Wilson-Cook Medical, Inc. | 2017-04-06 | 463 | 0 |
| K160170 | Lehman Manometry Catheter | Wilson-Cook Medical, Inc. | 2016-06-20 | 145 | 0 |
| K161203 | Soehendra Stent Retriever | Wilson-Cook Medical, Inc. | 2016-05-04 | 6 | 0 |
| K142950 | Acrobat Calibrated Tip Wire Guide | Wilson-Cook Medical, Inc. | 2014-11-05 | 26 | 0 |
| K141356 | ECHO TIP ULTRA FIDUCIAL NEEDLE | Wilson-Cook Medical, Inc. | 2014-06-20 | 28 | 0 |
| K132809 | INSTINCT ENDOSCOPIC HEMOCLIP | Wilson-Cook Medical, Inc. | 2013-10-25 | 46 | 0 |
| K122816 | AXCESS SOFT TIP WIRE GUIDE | Wilson-Cook Medical, Inc. | 2012-10-09 | 25 | 0 |
| K111495 | COOK GI ENDOSCOPIC INJECTION GEL KIT, GEL-S, GEL-N, GEL-H, G | Wilson-Cook Medical, Inc. | 2011-07-19 | 49 | 0 |
| K101095 | DIRECT PERORAL CHOLANGIOSCOPY BALLOON | Wilson-Cook Medical, Inc. | 2010-07-19 | 90 | 2 |
| K063677 | FUSION QUATTRO EXTRACTION BALLOON XL | Wilson-Cook Medical, Inc. | 2007-01-05 | 25 | 0 |
| K052051 | OMNI SPHINCTEROTOME | Wilson-Cook Medical, Inc. | 2005-08-05 | 7 | 2 |
| K043203 | WILSON-COOK ENTERAL FEEDING TUBE, TIGER TUBE ENTERAL FEEDING | Wilson-Cook Medical, Inc. | 2005-05-11 | 174 | 1 |
| K040930 | ZILVER BILIARY STENT SYSTEM USW | Wilson-Cook Medical, Inc. | 2004-07-02 | 84 | 0 |
| K040800 | WILOSN-COOK BILIARY DILATION BALLOON | Wilson-Cook Medical, Inc. | 2004-06-25 | 88 | 0 |
| K040324 | WILSON-COOK DOUBLE LUMEN BILIARY CYTOLOGY BRUSH | Wilson-Cook Medical, Inc. | 2004-05-20 | 100 | 0 |
| K040981 | USW NEEDLEKNIFE PAPILLOTOME | Wilson-Cook Medical, Inc. | 2004-05-07 | 22 | 0 |
| K040129 | TRI-EX EXTRACTION BALLOON WITH MULTIPLE SIZING | Wilson-Cook Medical, Inc. | 2004-02-27 | 37 | 0 |
| K040137 | WILSON-COOK USW CAP AND WIRE LOCK | Wilson-Cook Medical, Inc. | 2004-02-20 | 29 | 0 |
| K040151 | OASIS BILIARY STENT INTRODUCTION SYSTEM | Wilson-Cook Medical, Inc. | 2004-02-20 | 28 | 0 |
| K033754 | TRACER METRO SMART WIRE GUIDE | Wilson-Cook Medical, Inc. | 2003-12-30 | 29 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda