FDA Product Code ODD: Endoscopic Retrograde Cholangiopancreatography (ercp) Cannula
To Identify Stones, Tumors, Or Narrowing In The Biliary Tree.
Leading manufacturers include C.R. Bard, Inc., Boston Scientific Corp and Wilson-Cook Medical, 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
Cleared
May 27, 2025
Single Use Cannula V PR-V223Q/V414Q/V416Q/V418Q/V420Q/V427Q/V434Q/V435Q
Olympus Medical Systems Corp.
Gastroenterology & Urology
90d
Cleared
Nov 06, 2020
BioShield biopsy valve EUS - Linear
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
Wilson-Cook Medical, Inc.
Gastroenterology & Urology
260d
Cleared
Apr 30, 2001
ALIEN RX MICRO CANNULA, MODEL 4530
Boston Scientific Corp
Gastroenterology & Urology
27d
Cleared
Apr 27, 1995
BARD BILISYSTEM ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) CANNULA
C.R. Bard, Inc.
Gastroenterology & Urology
71d
Cleared
Jan 15, 1985
DAVOL ERCP CANNULA
C.R. Bard, Inc.
Gastroenterology & Urology
20d
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 →