K983525 is an FDA 510(k) clearance for the GORE REVOX THYROPLASTY IMPLANT. This device is classified as a System, Vocal Cord Medialization (Class II - Special Controls, product code MIX).
Submitted by W.L. Gore & Associates, Inc. (Elkton, US). The FDA issued a Cleared decision on December 10, 1998, 63 days after receiving the submission on October 8, 1998.
This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 874.3620.
| 510(k) Number | K983525 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 08, 1998 |
| Decision Date | December 10, 1998 |
| Days to Decision | 63 days |
| Submission Type | Traditional |
| Review Panel | Ear, Nose, Throat (EN) |
| Summary | Summary PDF |
| Product Code | MIX — System, Vocal Cord Medialization |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 874.3620 |