FDA 510(k) Applications for Medical Device Product Code "ODD"
(Endoscopic Retrograde Cholangiopancreatography (Ercp) Cannula)

FDA 510(k) Number Applicant Device Name Decision Date
K953967 ACT MEDICAL, INC. ENDOSCOPIC CATHETER 01/22/1996
K010993 BOSTON SCIENTIFIC CORP. ALIEN RX MICRO CANNULA, MODEL 4530 04/30/2001
K202583 Steris Corporation BioShield biopsy valve EUS - Linear 11/06/2020
K011149 THE OLYMPUS OPTICAL CO. DISPOSABLE BENDING CANNULA PR-233Q 05/15/2001
K070420 UNITED STATES ENDOSCOPY GROUP, INC. BIOSHIELD-ERCP BIOPSY VALVE, MODEL 00711138 03/19/2007
K963051 UNITED STATES ENDOSCOPY GROUP, INC. ERCP CANNULA 03/28/1997
K171989 Wilson-Cook Medical Inc. 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 R 03/20/2018
K973205 WILSON-COOK MEDICAL, INC. WILSON-COOK STRICTURE MEASURING CATHETER 11/24/1997


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