Wilson-Cook Medical, Inc. - FDA 510(k) Cleared Devices
Recent clearances: Hemospray Endoscopic Hemostat (HEMO-[X]), Teslatome Bipolar Sphincterotome, Entuit PEG, Entuit PEGJ
125
Total
118
Cleared
1
Denied
FDA 510(k) Regulatory Record - Wilson-Cook Medical, Inc. Gastroenterology & Urology ✕
110 devices
Cleared
Jan 17, 2025
Teslatome Bipolar Sphincterotome
Gastroenterology & Urology
60d
Cleared
Jan 20, 2022
Entuit PEG, Entuit PEGJ
Gastroenterology & Urology
100d
Cleared
Aug 25, 2021
Instinct Plus Endoscopic Clipping Device
Gastroenterology & Urology
30d
Cleared
Jun 17, 2020
Entuit Nasal Jejunal Feeding Tube
Gastroenterology & Urology
30d
Cleared
Feb 27, 2020
Fusion Quattro Extraction Balloon
Gastroenterology & Urology
27d
Cleared
Jan 30, 2020
TeslaTome Bipolar Sphincterotome, Tesla Bipolar Active Cord
Gastroenterology & Urology
155d
Cleared
Dec 13, 2019
Tri-Ex Extraction Balloon with Multiple Sizing
Gastroenterology & Urology
10d
Cleared
Nov 14, 2019
Fusion Cytology Brush, CytoMax II Double Lumen Cytology Brushes
Gastroenterology & Urology
30d
Cleared
Jul 18, 2019
AcuSnare Polypectomy Snare - Duckbill
Gastroenterology & Urology
90d
Cleared
May 29, 2019
Entuit PEG, Entuit PEGJ
Gastroenterology & Urology
177d
Cleared
Feb 08, 2019
Fusion Cytology Brush, CytoMax II Double Lumen Cytology Brush
Gastroenterology & Urology
266d
Cleared
Feb 01, 2019
Glo-Tip Spray Catheter
Gastroenterology & Urology
158d
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