K894580 is an FDA 510(k) clearance for the GORE-TEX SURGICAL TAPE. This device is classified as a Mesh, Surgical (Class II - Special Controls, product code FTM).
Submitted by W.L. Gore & Associates, Inc. (Flagstaff, US). The FDA issued a Cleared decision on October 10, 1989, 78 days after receiving the submission on July 24, 1989.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.3300.
| 510(k) Number | K894580 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 24, 1989 |
| Decision Date | October 10, 1989 |
| Days to Decision | 78 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 |