FDA Product Code
FDA Product Code ODD — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Gastroenterology, Urology
- 21 CFR Citation
- 876.1500
510(k) Clearances — 18 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K250573 | Single Use Cannula V PR-V223Q/V414Q/V416Q/V418Q/V420Q/V427Q/V434Q/V435Q; Single Use 2-Lumen Cannula V PR-V614M | Olympus Medical Systems Corp. | 2025-05-27 | Traditional | PDF ↗ |
| K202583 | BioShield biopsy valve EUS - Linear | STERIS Corporation | 2020-11-06 | Traditional | PDF ↗ |
| K171989 | 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. | 2018-03-20 | Traditional | PDF ↗ |
| K070420 | BIOSHIELD-ERCP BIOPSY VALVE, MODEL 00711138 | United States Endoscopy Group, Inc. | 2007-03-19 | Traditional | PDF ↗ |
| K011149 | DISPOSABLE BENDING CANNULA PR-233Q | The Olympus Optical Co. | 2001-05-15 | Special | PDF ↗ |
| K010993 | ALIEN RX MICRO CANNULA, MODEL 4530 | Boston Scientific Corp | 2001-04-30 | Special | PDF ↗ |
| K973205 | WILSON-COOK STRICTURE MEASURING CATHETER | Wilson-Cook Medical, Inc. | 1997-11-24 | Traditional | PDF ↗ |
| K963051 | ERCP CANNULA | United States Endoscopy Group, Inc. | 1997-03-28 | Traditional | PDF ↗ |
| K953967 | ENDOSCOPIC CATHETER | Act Medical, Inc. | 1996-01-22 | Traditional | PDF ↗ |
| K950700 | BARD BILISYSTEM ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) CANNULA | C.R. Bard, Inc. | 1995-04-27 | Traditional | PDF ↗ |
| K950729 | OLYMPUS PR-23Q DISPOSABLE CANNULA (BALL TIP) | Olympus America, Inc. | 1995-03-17 | Traditional | PDF ↗ |
| K910769 | SURGITEK(R) ERCP CONTRAST MEDIA SYSTEM | Surgitek Medical Engineering Corp. | 1991-06-25 | Traditional | PDF ↗ |
| K884709 | ENDOSCOPES & ACCESS.(SCLEROTHERAPY/TRANSBRONCHIAL) | Primrose Medical, Inc. | 1989-09-08 | Traditional | PDF ↗ |
| K845018 | DAVOL ERCP CANNULA | C.R. Bard, Inc. | 1985-01-15 | Traditional | PDF ↗ |
| K834414 | ERCP CANNULA | Hobbs Medical, Inc. | 1984-02-04 | Traditional | PDF ↗ |
| K833417 | ENDOSCOPIC RETROGRADE | Microvasive | 1983-11-28 | Traditional | PDF ↗ |
| K820431 | E.R.C.P. CANNULAS | American Endoscopy, Inc. | 1982-04-09 | Traditional | PDF ↗ |
| K802443 | E.R.C.P. CANNULA PRODUCT | Mill-Rose Laboratory | 1980-10-23 | Traditional | PDF ↗ |
Product code ODD · Class II · Gastroenterology, Urology. Data: openFDA.