K192490 is an FDA 510(k) clearance for the Tevdek II, Silky II Polydek, 'Cottony' II, NextStitch. This device is classified as a Suture, Nonabsorbable, Synthetic, Polyethylene (Class II - Special Controls, product code GAT).
Submitted by Teleflex Medical (Morrisville, US). The FDA issued a Cleared decision on March 30, 2020, 201 days after receiving the submission on September 11, 2019.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.5000.
| 510(k) Number | K192490 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 11, 2019 |
| Decision Date | March 30, 2020 |
| Days to Decision | 201 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 |