K831516 is an FDA 510(k) clearance for the GORE-TEX SURGICAL MEMBRANE. This device is classified as a Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene (Class II - Special Controls, product code DXZ).
Submitted by W.L. Gore & Associates, Inc. (Walker, US). The FDA issued a Cleared decision on January 6, 1984, 302 days after receiving the submission on March 10, 1983.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.3470.
| 510(k) Number | K831516 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 10, 1983 |
| Decision Date | January 06, 1984 |
| Days to Decision | 302 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | — |
| Product Code | DXZ — Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.3470 |