K913841 is an FDA 510(k) clearance for the 2 LUMEN ENDOS RETRO CHOLANGIOPANCREA INJEC CATH. This device is classified as a Stents, Drains And Dilators For The Biliary Ducts (Class II — Special Controls, product code FGE).
Submitted by Endovations (Mechanicsburg, US). The FDA issued a Cleared decision on October 8, 1991, 43 days after receiving the submission on August 26, 1991.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5010.
| 510(k) Number | K913841 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | August 26, 1991 |
| Decision Date | October 08, 1991 |
| Days to Decision | 43 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 |