K851086 is an FDA 510(k) clearance for the VICRYL (POLYGLACTIN 910/MERSILENE COMPOISITE MESH. This device is classified as a Mesh, Surgical (Class II - Special Controls, product code FTM).
Submitted by Ethicon, Inc. (Somerville, US). The FDA issued a Cleared decision on May 21, 1985, 64 days after receiving the submission on March 18, 1985.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.3300.
| 510(k) Number | K851086 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 18, 1985 |
| Decision Date | May 21, 1985 |
| Days to Decision | 64 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | — |
| Product Code | FTM — Mesh, Surgical |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.3300 |