K041216 is an FDA 510(k) clearance for the SMITH & NEPHEW ULTRABRAID SUTURE. 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 June 7, 2004, 28 days after receiving the submission on May 10, 2004.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.5000.
| 510(k) Number | K041216 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 10, 2004 |
| Decision Date | June 07, 2004 |
| Days to Decision | 28 days |
| Submission Type | Abbreviated |
| 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 |