K984550 is an FDA 510(k) clearance for the PRE-THREADED ENDOBUTTON. This device is classified as a Suture, Nonabsorbable, Synthetic, Polyethylene (Class II - Special Controls, product code GAT).
Submitted by Smith & Nephew, Inc. (Mansfield, US). The FDA issued a Cleared decision on March 1, 1999, 69 days after receiving the submission on December 22, 1998.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.5000.
| 510(k) Number | K984550 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 22, 1998 |
| Decision Date | March 01, 1999 |
| Days to Decision | 69 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | GAT — Suture, Nonabsorbable, Synthetic, Polyethylene |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.5000 |