K942987 is an FDA 510(k) clearance for the NUCLEOTOME L KIT, a Motor, Surgical Instrument, Pneumatic Powered (Class I — General Controls, product code GET), submitted by Surgical Dynamics, Inc. (Concord, US). The FDA issued a Cleared decision on October 30, 1995, 497 days after receiving the submission on June 20, 1994. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4820.
| 510(k) Number | K942987 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | June 20, 1994 |
| Decision Date | October 30, 1995 |
| Days to Decision | 497 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | GET — Motor, Surgical Instrument, Pneumatic Powered |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 878.4820 |