510(k) K833417
- Device
- ENDOSCOPIC RETROGRADE
- Applicant
- MICROVASIVE
- 510(k) number
- K833417
- Product code
- ODD
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1983-11-28
- Date received
- 1983-10-03
- Regulation
- 876.1500
- Classification name
- Endoscopic Retrograde Cholangiopancreatography (ercp) Cannula
- Medical specialty
- Gastroenterology/Urology
- Review panel
- Gastroenterology/Urology
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
FDA Registration Numbers#
- 3014769442
- 3007695959
- 3017210488
- 2528981
- 9680001
- 1223925
- 1320894
- 2246552
- 3005099803
- 3007305485
- 1000121056
- 1037905
- 9614641
- 8010047
- 1000393132
- 1047843
- 1528319
- 1319639
- 9681260
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code ODD #
| 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 with DomeTip, Haber RAMP Catheter, Soehendra Universal Catheter | 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 |
Legacy Summary#
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FDA Review#
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