K192953 is an FDA 510(k) clearance for the APTOS Threads – Polypropylene Surgical Sutures. This device is classified as a Suture, Nonabsorbable, Synthetic, Polypropylene (Class II - Special Controls, product code GAW).
Submitted by Aptos, LLC (Tbilisi, GE). The FDA issued a Cleared decision on August 27, 2020, 311 days after receiving the submission on October 21, 2019.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.5010.
| 510(k) Number | K192953 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 21, 2019 |
| Decision Date | August 27, 2020 |
| Days to Decision | 311 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | GAW - Suture, Nonabsorbable, Synthetic, Polypropylene |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.5010 |