FDA Product Code ODD: Endoscopic Retrograde Cholangiopancreatography (ercp) Cannula
To Identify Stones, Tumors, Or Narrowing In The Biliary Tree.
Leading manufacturers include Olympus Medical Systems Corp..
FDA 510(k) Cleared Endoscopic Retrograde Cholangiopancreatography (ercp) Cannula Devices (Product Code ODD)
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 Review Time
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 →