K924107 is an FDA 510(k) clearance for the ERCP CANNULA. This device is classified as a Stents, Drains And Dilators For The Biliary Ducts (Class II - Special Controls, product code FGE).
Submitted by United States Endoscopy Group, Inc. (Waite Hill, US). The FDA issued a Cleared decision on December 30, 1992, 139 days after receiving the submission on August 13, 1992.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5010.
| 510(k) Number | K924107 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 13, 1992 |
| Decision Date | December 30, 1992 |
| Days to Decision | 139 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Statement |
| Product Code | FGE - Stents, Drains And Dilators For The Biliary Ducts |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5010 |