ODD — Endoscopic Retrograde Cholangiopancreatography (Ercp) Cannula Class II

FDA Device Classification

Classification Details

Product Code
ODD
Device Class
Class II
Regulation Number
876.1500
Submission Type
Review Panel
GU
Medical Specialty
Gastroenterology, Urology
Implant
No

Definition

To identify stones, tumors, or narrowing in the biliary tree.

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K250573olympus medical systemsSingle Use Cannula V PR-V223Q/V414Q/V416Q/V418Q/V420Q/V427Q/V434Q/V435Q; Single May 27, 2025
K202583steris corporationBioShield biopsy valve EUS - LinearNovember 6, 2020
K171989wilson-cook medicalClassic ERCP Catheter and Huibregtse-Katon ERCP Catheter and Huibregtse-Katon AnMarch 20, 2018
K070420united states endoscopy groupBIOSHIELD-ERCP BIOPSY VALVE, MODEL 00711138March 19, 2007
K011149olympus opticalDISPOSABLE BENDING CANNULA PR-233QMay 15, 2001
K010993boston scientificALIEN RX MICRO CANNULA, MODEL 4530April 30, 2001
K973205wilson-cook medicalWILSON-COOK STRICTURE MEASURING CATHETERNovember 24, 1997
K963051united states endoscopy groupERCP CANNULAMarch 28, 1997
K953967act medicalENDOSCOPIC CATHETERJanuary 22, 1996
K950700c.r. bardBARD BILISYSTEM ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) CANNULAApril 27, 1995
K950729olympus americaOLYMPUS PR-23Q DISPOSABLE CANNULA (BALL TIP)March 17, 1995
K910769surgitek medical engineeringSURGITEK(R) ERCP CONTRAST MEDIA SYSTEMJune 25, 1991
K884709primrose medicalENDOSCOPES & ACCESS.(SCLEROTHERAPY/TRANSBRONCHIAL)September 8, 1989
K845018c.r. bardDAVOL ERCP CANNULAJanuary 15, 1985
K834414hobbs medicalERCP CANNULAFebruary 4, 1984
K833417microvasiveENDOSCOPIC RETROGRADENovember 28, 1983
K820431american endoscopyE.R.C.P. CANNULASApril 9, 1982
K802443mill-rose laboratoryE.R.C.P. CANNULA PRODUCTOctober 23, 1980