K954470 is an FDA 510(k) clearance for the SURGIMOTOR. This device is classified as a Motor, Surgical Instrument, Ac-powered (Class I - General Controls, product code GEY).
Submitted by W.O.M. World of Medicine GmbH (Washington, US). The FDA issued a Cleared decision on December 8, 1995, 73 days after receiving the submission on September 26, 1995.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4820.
| 510(k) Number | K954470 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 26, 1995 |
| Decision Date | December 08, 1995 |
| Days to Decision | 73 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Statement |
| Product Code | GEY — Motor, Surgical Instrument, Ac-powered |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 878.4820 |