K941350 is an FDA 510(k) clearance for the WILSON-COOK GIANTURCO-ROSCH Z-STENT AND INTRODUCER. This device is classified as a Stents, Drains And Dilators For The Biliary Ducts (Class II - Special Controls, product code FGE).
Submitted by Wilson-Cook Medical, Inc. (Winston-Salem, US). The FDA issued a Cleared decision on March 9, 1995, 353 days after receiving the submission on March 21, 1994.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5010.
| 510(k) Number | K941350 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 21, 1994 |
| Decision Date | March 09, 1995 |
| Days to Decision | 353 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 |