K201934 is an FDA 510(k) clearance for the Surgimatix Absorbable Fixation System. This device is classified as a Staple, Implantable (Class II - Special Controls, product code GDW).
Submitted by Surgimatix, Inc. (Elk Grove Village, US). The FDA issued a Cleared decision on October 1, 2021, 445 days after receiving the submission on July 13, 2020.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4750.
| 510(k) Number | K201934 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 13, 2020 |
| Decision Date | October 01, 2021 |
| Days to Decision | 445 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | GDW - Staple, Implantable |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4750 |