E.R.C.P. Cannulas
FDA 510(k) K820431 · American Endoscopy, Inc.
510(k) numberK820431
Submission
- Device name
- E.R.C.P. Cannulas
- Applicant
- American Endoscopy, Inc.
Mchenry, IL, US - Received
- February 17, 1982
- Decision date
- April 9, 1982
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- ODD – Endoscopic Retrograde Cholangiopancreatography (Ercp) Cannula
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1500
- Specialty
- Gastroenterology, Urology
To identify stones, tumors, or narrowing in the biliary tree.
Other 510(k)s with product code ODD
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K250573 | Single Use Cannula V PR-V223Q/V414Q/V416Q/V418Q/V420Q/V427Q/V434Q/V435Q; Single Use…ODD · Traditional | Olympus Medical Systems Corp. | 05/27/2025SE |
| K202583 | BioShield biopsy valve EUS - LinearODD · Traditional | STERIS Corporation | 11/06/2020SE |
| K171989 | Classic ERCP Catheter and Huibregtse-Katon ERCP Catheter and Huibregtse-Katon Angled…ODD · Traditional | Wilson-Cook Medical, Inc. | 03/20/2018SE |
| K070420 | Bioshield-Ercp Biopsy Valve, Model 00711138ODD · Traditional | United States Endoscopy Group, Inc. | 03/19/2007SE |
| K011149 | Disposable Bending Cannula PR-233QODD · Special | The Olympus Optical Co. | 05/15/2001SE |
| K010993 | Alien RX Micro Cannula, Model 4530ODD · Special | Boston Scientific Corp | 04/30/2001SE |
| K973205 | Wilson-Cook Stricture Measuring CatheterODD · Traditional | Wilson-Cook Medical, Inc. | 11/24/1997SE |
| K963051 | Ercp CannulaODD · Traditional | United States Endoscopy Group, Inc. | 03/28/1997SE |
| K953967 | Endoscopic CatheterODD · Traditional | Act Medical, Inc. | 01/22/1996SE |
| K950700 | Bard Bilisystem Endoscopic Retrograde Cholangiopancreatography (Ercp) CannulaODD · Traditional | C.R. Bard, Inc. | 04/27/1995SE |
More from C.R. Bard, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K853274 | American Dilatation SystemKNQ · Traditional | 10/17/1985SE |
| K841384 | Proxima 1 PH MonitorFFT · Traditional | 07/19/1984SE |
| K833491 | Endo Bite BlockKTI · Traditional | 04/25/1984SE |
| K840818 | Biopsy ForcepsFCL · Traditional | 04/13/1984SE |
| K833859 | Tamponade Balloon CuffGCP · Traditional | 01/03/1984SE |
| K833492 | Percutaneous Endoscopic GastroscopyKNT · Traditional | 11/29/1983SE |
| K832458 | Automatic EndoscopeNVE · Traditional | 10/20/1983SE |
| K821818 | Retrieval BalloonsKOD · Traditional | 09/24/1982SE |
| K821819 | Pigtail StentsFGE · Traditional | 08/20/1982SE |
| K822062 | Ball Tip Coagulating ElectrodesGEI · Traditional | 08/19/1982SE |
Questions and answers
When was E.R.C.P. Cannulas cleared by the FDA?
E.R.C.P. Cannulas (K820431) received a 510(k) decision of Substantially Equivalent on April 9, 1982, 51 days after the submission was received.
What is the product code of K820431?
The FDA product code is ODD – Endoscopic Retrograde Cholangiopancreatography (Ercp) Cannula, a Class II (moderate risk) device regulated under 21 CFR 876.1500.