K023088 is an FDA 510(k) clearance for the BONE GRAFT SYRINGE, MODEL 8600-00X0. This device is classified as a Syringe, Piston (Class II - Special Controls, product code FMF).
Submitted by Wrightmedicaltechnologyinc (Arlington, US). The FDA issued a Cleared decision on October 2, 2002, 15 days after receiving the submission on September 17, 2002.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5860.
| 510(k) Number | K023088 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 17, 2002 |
| Decision Date | October 02, 2002 |
| Days to Decision | 15 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 |