K963051 is an FDA 510(k) clearance for the ERCP CANNULA. This device is classified as a Endoscopic Retrograde Cholangiopancreatography (ercp) Cannula (Class II - Special Controls, product code ODD).
Submitted by United States Endoscopy Group, Inc. (Mentor, US). The FDA issued a Cleared decision on March 28, 1997, 234 days after receiving the submission on August 6, 1996.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.1500. To Identify Stones, Tumors, Or Narrowing In The Biliary Tree..
| 510(k) Number | K963051 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 06, 1996 |
| Decision Date | March 28, 1997 |
| Days to Decision | 234 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | ODD - Endoscopic Retrograde Cholangiopancreatography (ercp) Cannula |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.1500 |
| Definition | To Identify Stones, Tumors, Or Narrowing In The Biliary Tree. |