ODD — Endoscopic Retrograde Cholangiopancreatography (Ercp) Cannula Class II
FDA product code ODD covers "Endoscopic Retrograde Cholangiopancreatography (Ercp) Cannula", a Class II medical device regulated under 21 CFR 876.1500. Submissions are reviewed by the Gastroenterology, Urology panel. At least 18 recent 510(k) clearances have been granted under this product code.
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-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K250573 | olympus medical systems | Single Use Cannula V PR-V223Q/V414Q/V416Q/V418Q/V420Q/V427Q/V434Q/V435Q; Single | May 27, 2025 |
| K202583 | steris corporation | BioShield biopsy valve EUS - Linear | November 6, 2020 |
| K171989 | wilson-cook medical | Classic ERCP Catheter and Huibregtse-Katon ERCP Catheter and Huibregtse-Katon An | March 20, 2018 |
| K070420 | united states endoscopy group | BIOSHIELD-ERCP BIOPSY VALVE, MODEL 00711138 | March 19, 2007 |
| K011149 | olympus optical | DISPOSABLE BENDING CANNULA PR-233Q | May 15, 2001 |
| K010993 | boston scientific | ALIEN RX MICRO CANNULA, MODEL 4530 | April 30, 2001 |
| K973205 | wilson-cook medical | WILSON-COOK STRICTURE MEASURING CATHETER | November 24, 1997 |
| K963051 | united states endoscopy group | ERCP CANNULA | March 28, 1997 |
| K953967 | act medical | ENDOSCOPIC CATHETER | January 22, 1996 |
| K950700 | c.r. bard | BARD BILISYSTEM ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) CANNULA | April 27, 1995 |
| K950729 | olympus america | OLYMPUS PR-23Q DISPOSABLE CANNULA (BALL TIP) | March 17, 1995 |
| K910769 | surgitek medical engineering | SURGITEK(R) ERCP CONTRAST MEDIA SYSTEM | June 25, 1991 |
| K884709 | primrose medical | ENDOSCOPES & ACCESS.(SCLEROTHERAPY/TRANSBRONCHIAL) | September 8, 1989 |
| K845018 | c.r. bard | DAVOL ERCP CANNULA | January 15, 1985 |
| K834414 | hobbs medical | ERCP CANNULA | February 4, 1984 |
| K833417 | microvasive | ENDOSCOPIC RETROGRADE | November 28, 1983 |
| K820431 | american endoscopy | E.R.C.P. CANNULAS | April 9, 1982 |
| K802443 | mill-rose laboratory | E.R.C.P. CANNULA PRODUCT | October 23, 1980 |