# Wilson-Cook Medical, Inc.

- Location (FDA's records): Winston-Salem, NC
- FDA decisions: 127 (1985–2026): 126 510(k) clearances and 1 De Novo grant
- Names in FDA's records: Wilson-Cook Medical, Inc. (125); Wilson Cook Medical (1); Wilson-Cook Medical (1)
- Product codes: FGE (20), KNT (12), KNS (12), GCA (7), FDX (5), FCG (5), OCY (5), FBK (4), ESW (3), KGE (3), LQR (3), PKL (3)
- 510(k) review time since 2016: median 155 days, against 145 for FDA's reviews in the same codes and years (10 of 23 faster)
- Predicates its devices cite: 75 (50 its own); citations of its devices by later devices: 131 (50 its own)
- Recalls linked to its devices: 50 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Boston Scientific Corp: 6 (https://510kreport.com/company/boston-scientific)
- Wilson-Cook Medical Inc./Cook Endoscopy: 5 (https://510kreport.com/company/wilson-cook-medical-cook-endoscopy)
- Cook Endoscopy: 2 (https://510kreport.com/company/cook-endoscopy)
- Proact, Ltd.: 1 (https://510kreport.com/company/proact)
- Mill-Rose Laboratory: 1 (https://510kreport.com/company/mill-rose-laboratory)
- N.M. Beale Co., Inc.: 1 (https://510kreport.com/company/nm-beale)
- Ximed/Prosure/Injectx: 1 (https://510kreport.com/company/ximed-prosure-injectx)
- Olympus Medical Systems Corp.: 1 (https://510kreport.com/company/olympus-medical-systems)

## Firms that cite its devices most
- Cook Ireland, Ltd.: 15 (https://510kreport.com/company/cook-ireland)
- Wilson-Cook Medical Inc./Cook Endoscopy: 6 (https://510kreport.com/company/wilson-cook-medical-cook-endoscopy)
- Boston Scientific Corp: 6 (https://510kreport.com/company/boston-scientific)
- Cook Endoscopy: 4 (https://510kreport.com/company/cook-endoscopy)
- Hangzhou AGS MedTech Co., Ltd.: 4 (https://510kreport.com/company/hangzhou-ags-medtech)
- Medi-Globe Corp.: 4 (https://510kreport.com/company/medi-globe)
- Micro-Tech (Nanjing) Co., Ltd.: 3 (https://510kreport.com/company/micro-tech-nanjing)
- Taewoong Medical Co., Ltd.: 3 (https://510kreport.com/company/taewoong-medical)

## Its most-cited devices
- K934356: Wilson-Cook GI Aspiration Needle (1994), cited by 6
- K022595: Wilson-Cook Cystotome (2002), cited by 6
- DEN170015: Hemospray Endoscopic Hemostat (2018), cited by 5
- K900923: Zimmon Endoscopic Pancreatic Stent (1990), cited by 4
- K935094: Balloon Dilation Catheter (1995), cited by 4
- K040137: Wilson-Cook Usw Cap and Wire Lock (2004), cited by 4

## Recent decisions
- K253302: Hemospray Endoscopic Hemostat (HEMO-[X]) (Jun 2, 2026)
- K251104: SureTome™ SW Sphincterotome with DomeTip (Sep 29, 2025)
- K243568: Teslatome Bipolar Sphincterotome; Tesla BiCord Active Cord (Jan 17, 2025)
- K213483: SnapLoc Wire Lock (Apr 26, 2022)
- K213356: Entuit PEG, Entuit PEGJ (Jan 20, 2022)
- K212323: Instinct Plus Endoscopic Clipping Device (Aug 25, 2021)
- K201322: Entuit Nasal Jejunal Feeding Tube (Jun 17, 2020)
- K200972: Hemospray Endoscopic Hemostat (Jun 10, 2020)

Source page: https://510kreport.com/company/wilson-cook-medical