K180937 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 May 10, 2018, 30 days after receiving the submission on April 10, 2018.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5860.
| 510(k) Number | K180937 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 10, 2018 |
| Decision Date | May 10, 2018 |
| Days to Decision | 30 days |
| Submission Type | Special |
| 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 |