K190707 is an FDA 510(k) clearance for the Arthrex SoftStitch. This device is classified as a Suture, Nonabsorbable, Synthetic, Polyethylene (Class II - Special Controls, product code GAT).
Submitted by Arthrex, Inc. (Naples, US). The FDA issued a Cleared decision on October 2, 2020, 563 days after receiving the submission on March 19, 2019.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.5000.
| 510(k) Number | K190707 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 19, 2019 |
| Decision Date | October 02, 2020 |
| Days to Decision | 563 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 |