K913986 is an FDA 510(k) clearance for the CHOLANGIOGRAPHY/CHOLANGIOSCOPY/LIHOPAXY SYSTEM. This device is classified as a Stents, Drains And Dilators For The Biliary Ducts (Class II - Special Controls, product code FGE).
Submitted by Medical Dynamics, Inc. (Englewood, US). The FDA issued a Cleared decision on January 28, 1992, 145 days after receiving the submission on September 5, 1991.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5010.
| 510(k) Number | K913986 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Special 510(k) (SESK) |
| Date Received | September 05, 1991 |
| Decision Date | January 28, 1992 |
| Days to Decision | 145 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | FGE — Stents, Drains And Dilators For The Biliary Ducts |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5010 |