K162252 is an FDA 510(k) clearance for the FasTouch Fixation System. This device is classified as a Staple, Implantable (Class II - Special Controls, product code GDW).
Submitted by Via Surgical , Ltd. (Moshav Amirim, IL). The FDA issued a Cleared decision on November 14, 2016, 96 days after receiving the submission on August 10, 2016.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4750.
| 510(k) Number | K162252 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 10, 2016 |
| Decision Date | November 14, 2016 |
| Days to Decision | 96 days |
| Submission Type | Special |
| 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 |