Product code ODD
- Device name
- Endoscopic Retrograde Cholangiopancreatography (Ercp) Cannula
- Medical specialty
- Gastroenterology, Urology
- Device class
- 2
- Regulation number
- 876.1500
- Review panel
- GU
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Definition
- To identify stones, tumors, or narrowing in the biliary tree.
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| 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 |
| K202583 | BioShield biopsy valve EUS - Linear | STERIS Corporation | 2020-11-06 |
| 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 wit... | Wilson-Cook Medical, Inc. | 2018-03-20 |
| K070420 | BIOSHIELD-ERCP BIOPSY VALVE, MODEL 00711138 | United States Endoscopy Group, Inc. | 2007-03-19 |
| K011149 | DISPOSABLE BENDING CANNULA PR-233Q | The Olympus Optical Co. | 2001-05-15 |
| K010993 | ALIEN RX MICRO CANNULA, MODEL 4530 | Boston Scientific Corp | 2001-04-30 |
| K973205 | WILSON-COOK STRICTURE MEASURING CATHETER | Wilson-Cook Medical, Inc. | 1997-11-24 |
| K963051 | ERCP CANNULA | United States Endoscopy Group, Inc. | 1997-03-28 |
| K953967 | ENDOSCOPIC CATHETER | Act Medical, Inc. | 1996-01-22 |
| K950700 | BARD BILISYSTEM ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) CANNULA | C.R. Bard, Inc. | 1995-04-27 |
| K950729 | OLYMPUS PR-23Q DISPOSABLE CANNULA (BALL TIP) | Olympus America, Inc. | 1995-03-17 |
| K910769 | SURGITEK(R) ERCP CONTRAST MEDIA SYSTEM | Surgitek Medical Engineering Corp. | 1991-06-25 |
| K884709 | ENDOSCOPES & ACCESS.(SCLEROTHERAPY/TRANSBRONCHIAL) | Primrose Medical, Inc. | 1989-09-08 |
| K845018 | DAVOL ERCP CANNULA | C.R. Bard, Inc. | 1985-01-15 |
| K834414 | ERCP CANNULA | Hobbs Medical, Inc. | 1984-02-04 |
| K833417 | ENDOSCOPIC RETROGRADE | Microvasive | 1983-11-28 |
| K820431 | E.R.C.P. CANNULAS | American Endoscopy, Inc. | 1982-04-09 |
| K802443 | E.R.C.P. CANNULA PRODUCT | Mill-Rose Laboratory | 1980-10-23 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
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| 00724995199241 | BioShield | US Endoscopy | 2021-09-15 |
| 00724995190767 | UroSeal | US Endoscopy | 2020-04-02 |
| 10724995183544 | BioShield | US Endoscopy | 2020-03-19 |
| 00724995183486 | BioShield | US Endoscopy | 2020-03-19 |
| 00724995183509 | BioShield | US Endoscopy | 2020-03-19 |
| 00724995183516 | BioShield | US Endoscopy | 2020-03-19 |
| 00724995183523 | BioShield | US Endoscopy | 2020-03-19 |
| 00724995183554 | BioShield | US Endoscopy | 2020-03-19 |
| 00724995183561 | BioShield | US Endoscopy | 2020-03-19 |
| 00724995183578 | BioShield | US Endoscopy | 2020-03-19 |
| 10724995183537 | BioShield | US Endoscopy | 2020-03-19 |
| 10724995183490 | BioShield | US Endoscopy | 2020-03-19 |
| 00724995183585 | BioShield | US Endoscopy | 2020-03-19 |
| 00724995183592 | BioShield | US Endoscopy | 2020-03-19 |
| 20653405051272 | PROFORMA | Conmed Corporation | 2016-09-24 |
| 20653405055416 | PROFORMA | Conmed Corporation | 2016-09-24 |
| 20653405051296 | PROFORMA | Conmed Corporation | 2016-09-24 |
| 08714729099789 | Contour ERCP Cannula | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| 20653405051265 | PROFORMA | Conmed Corporation | 2016-09-24 |
| 20653405051258 | PROFORMA | Conmed Corporation | 2016-09-24 |
| 20653405051241 | PROFORMA | Conmed Corporation | 2016-09-24 |
| 20653405051234 | PROFORMA | Conmed Corporation | 2016-09-24 |
| 08714729146636 | Tandem XL | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| 08714729099840 | Contour ERCP Cannula | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| 08714729099833 | Contour ERCP Cannula | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| 08714729099826 | Contour ERCP Cannula | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| 08714729099819 | Contour ERCP Cannula | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| 10816765013400 | BioShield | US Endoscopy | 2016-09-17 |
| 10816765013394 | BioShield | US Endoscopy | 2016-09-17 |