Wilson-Cook Medical Inc./Cook Endoscopy - FDA 510(k) Cleared Devices
Recent clearances: Gastrointestinal Injection Needles (VIN, LDVI, DVI and MHI), Classic Cotton Cannulatome®, CannulaTome II® Double Lumen Sphincterotome, Cotton CannulaTome II® PC, UTS® Ultra Taper Sphincterotome, Tri-Tome pc® Triple Lumen Sphincterotome, Howell D.A.S.H.® Sphincterotome with DomeTip®, Billroth II Sphincterotome, Soehendra® BII Sphincterotome, Models ACU-1 and ACU-1-VL active cords, Fusion OMNI Sphincterotome
7
Total
7
Cleared
0
Denied
FDA 510(k) Regulatory Record - Wilson-Cook Medical Inc./Cook Endoscopy Gastroenterology & Urology ✕
6 devices
Cleared
Dec 19, 2019
Gastrointestinal Injection Needles (VIN, LDVI, DVI and MHI)
Gastroenterology & Urology
262d
Cleared
May 24, 2018
Classic Cotton Cannulatome®, CannulaTome II® Double Lumen Sphincterotome,...
Gastroenterology & Urology
261d
Cleared
Apr 17, 2018
Fusion OMNI Sphincterotome
Gastroenterology & Urology
260d
Cleared
Aug 17, 2017
Zimmon Needle Knife Papillotome
Gastroenterology & Urology
45d
Cleared
Jul 31, 2017
Bronchi and Gastrointestinal Cytology Brush
Gastroenterology & Urology
60d
Cleared
Aug 31, 2012
DISPOSABLE HEMOSTASIS CHIP
Gastroenterology & Urology
102d