FDA product code ODD: Endoscopic Retrograde Cholangiopancreatography (Ercp) Cannula
ODD is the FDA product code for endoscopic retrograde cholangiopancreatography (ercp) cannula. It is a Class II device, regulated under 21 CFR 876.1500 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 18 510(k) submissions under ODD, 1 in the last five years, from 15 different applicants. The average 510(k) review took 94 days (median 58); 90 days on average over the last three years.
Definition
To identify stones, tumors, or narrowing in the biliary tree.
Classification
| Field | Value |
|---|---|
| Device name | Endoscopic Retrograde Cholangiopancreatography (Ercp) Cannula |
| Device class | Class II |
| Regulation | 21 CFR 876.1500 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) |
510(k) clearances per year for ODD
| Year | Clearances | Avg. review days |
|---|---|---|
| 2018 | 1 | 260 |
| 2020 | 1 | 59 |
| 2025 | 1 | 90 |
Compare with all 510(k) review times · Search every ODD clearance
Top ODD applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Wilson-Cook Medical, Inc. | 2 | 2018-03-20 |
| United States Endoscopy Group, Inc. | 2 | 2007-03-19 |
| C.R. Bard, Inc. | 2 | 1995-04-27 |
| Olympus Medical Systems Corp. | 1 | 2025-05-27 |
| STERIS Corporation | 1 | 2020-11-06 |
10 more applicants have ODD clearances. See the full list in Caduvo.
Most recent ODD clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K250573 | Olympus Medical Systems Corp. | Single Use Cannula V PR-V223Q/V414Q/V416Q/V418Q/V420Q/V427Q/V434Q/V435Q; Single Use 2-Lumen Cannula V PR-V614M | 2025-05-27 | 90 |
| K202583 | STERIS Corporation | BioShield biopsy valve EUS - Linear | 2020-11-06 | 59 |
| K171989 | Wilson-Cook Medical, Inc. | 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 | 2018-03-20 | 260 |
| K070420 | United States Endoscopy Group, Inc. | BIOSHIELD-ERCP BIOPSY VALVE, MODEL 00711138 | 2007-03-19 | 27 |
| K011149 | The Olympus Optical Co. | DISPOSABLE BENDING CANNULA PR-233Q | 2001-05-15 | 29 |
Recalls for ODD devices
openFDA lists no recalls for product code ODD.
Frequently asked questions
What is FDA product code ODD?
ODD is the FDA product code for endoscopic retrograde cholangiopancreatography (ercp) cannula. It is a Class II device, regulated under 21 CFR 876.1500 and reviewed by the Gastroenterology and Urology panel.
What device class is ODD?
Class II, regulation 21 CFR 876.1500. Typical premarket route: 510(k).
How long does a 510(k) take for product code ODD?
Across 18 cleared submissions the average was 94 days from receipt to decision (median 58).
Which companies have the most ODD clearances?
Wilson-Cook Medical, Inc. (2); United States Endoscopy Group, Inc. (2); C.R. Bard, Inc. (2); Olympus Medical Systems Corp. (1); STERIS Corporation (1).
Next steps
- Run an FDA pathway report with predicate devices for product code ODD
- Run a recall and safety report across every ODD manufacturer
- Watch product code ODD for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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