ODD
- Product code
- ODD
- Device name
- Endoscopic Retrograde Cholangiopancreatography (Ercp) Cannula
- Device class
- Class 2
- 21 CFR
- 21 CFR 876.1500
- Medical specialty
- Gastroenterology, Urology
- Marketing pathway
- 510(K)
- 510(k) clearances (last 3 years)
- 1
- Summaries archived here
- 1 (direct download)
- 510(k) clearances (all years, FDA)
- 18 (all years; only the last 3 years are listed here)
FDA classification definition
To identify stones, tumors, or narrowing in the biliary tree.
510(k) clearances, last 3 years (1)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K250573 | 2025-05-27 | Olympus Medical Systems Corp. | Single Use Cannula V PR-V223Q/V414Q/V416Q/V418Q/V420… |
Official FDA classification page: ODD
Classification and pathway per current FDA publications. Data from openFDA (CC0).