K203117 is an FDA 510(k) clearance for the TissueTak device. This device is classified as a Staple, Implantable (Class II - Special Controls, product code GDW).
Submitted by Via Surgical , Ltd. (Amirim, IL). The FDA issued a Cleared decision on January 7, 2021, 83 days after receiving the submission on October 16, 2020.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4750.
| 510(k) Number | K203117 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 16, 2020 |
| Decision Date | January 07, 2021 |
| Days to Decision | 83 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 |