ODD · Class II · 21 CFR 876.1500

FDA Product Code ODD: Endoscopic Retrograde Cholangiopancreatography (ercp) Cannula

To Identify Stones, Tumors, Or Narrowing In The Biliary Tree.

Leading manufacturers include United States Endoscopy Group, Inc., Wilson-Cook Medical, Inc. and C.R. Bard, Inc..

18
Total
18
Cleared
94d
Avg days
1980
Since
Growing category - 1 submissions in the last 2 years vs 0 in the prior period
Consistent review times: 90d avg (recent)

FDA 510(k) Cleared Endoscopic Retrograde Cholangiopancreatography (ercp) Cannula Devices (Product Code ODD)

18 devices
1–18 of 18
Cleared May 27, 2025
Single Use Cannula V PR-V223Q/V414Q/V416Q/V418Q/V420Q/V427Q/V434Q/V435Q
K250573
Olympus Medical Systems Corp.
Gastroenterology & Urology · 90d
Cleared Nov 06, 2020
BioShield biopsy valve EUS - Linear
K202583
STERIS Corporation
Gastroenterology & Urology · 59d
Cleared Mar 20, 2018
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 RAMP Catheter, Soehendra Universal Catheter
K171989
Wilson-Cook Medical, Inc.
Gastroenterology & Urology · 260d
Cleared Mar 19, 2007
BIOSHIELD-ERCP BIOPSY VALVE, MODEL 00711138
K070420
United States Endoscopy Group, Inc.
Gastroenterology & Urology · 27d
Cleared Apr 30, 2001
ALIEN RX MICRO CANNULA, MODEL 4530
K010993
Boston Scientific Corp
Gastroenterology & Urology · 27d
Cleared Nov 24, 1997
WILSON-COOK STRICTURE MEASURING CATHETER
K973205
Wilson-Cook Medical, Inc.
Gastroenterology & Urology · 90d
Cleared Mar 28, 1997
ERCP CANNULA
K963051
United States Endoscopy Group, Inc.
Gastroenterology & Urology · 234d
Cleared Apr 27, 1995
BARD BILISYSTEM ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) CANNULA
K950700
C.R. Bard, Inc.
Gastroenterology & Urology · 71d
Cleared Mar 17, 1995
OLYMPUS PR-23Q DISPOSABLE CANNULA (BALL TIP)
K950729
Olympus America, Inc.
Gastroenterology & Urology · 29d
Cleared Jan 15, 1985
DAVOL ERCP CANNULA
K845018
C.R. Bard, Inc.
Gastroenterology & Urology · 20d
Cleared Oct 23, 1980
E.R.C.P. CANNULA PRODUCT
K802443
Mill-Rose Laboratory
Gastroenterology & Urology · 16d

About Product Code ODD - Regulatory Context

510(k) Submission Activity

18 total 510(k) submissions under product code ODD since 1980, with 18 receiving FDA clearance (average review time: 94 days).

Submission volume has increased in recent years - 1 submissions in the last 24 months compared to 0 in the prior period - suggesting growing market activity in this device classification.

FDA 510(k) Review Time - ODD Product Code

FDA review times for ODD submissions have been consistent, averaging 90 days recently vs 94 days historically.

ODD devices are reviewed by the Gastroenterology & Urology panel. Browse all Gastroenterology & Urology devices →