K170675 is an FDA 510(k) clearance for the Graftgun Universal Graft Delivery System. This device is classified as a Syringe, Piston (Class II - Special Controls, product code FMF).
Submitted by SurGenTec, LLC (Boca Raton, US). The FDA issued a Cleared decision on July 19, 2017, 135 days after receiving the submission on March 6, 2017.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5860.
| 510(k) Number | K170675 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 06, 2017 |
| Decision Date | July 19, 2017 |
| Days to Decision | 135 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | FMF — Syringe, Piston |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5860 |