K012738 is an FDA 510(k) clearance for the SYMPHONY GRAFT DELIVERY SYSTEM (GDS), a Motor, Surgical Instrument, Ac-powered (Class I — General Controls, product code GEY), submitted by Depuyacromed (Raynham, US). The FDA issued a Cleared decision on November 14, 2001, 90 days after receiving the submission on August 16, 2001. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4820.
| 510(k) Number | K012738 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | August 16, 2001 |
| Decision Date | November 14, 2001 |
| Days to Decision | 90 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | GEY — Motor, Surgical Instrument, Ac-powered |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 878.4820 |