K870157 is an FDA 510(k) clearance for the OSCILLATING SAW/ RECIPROCATING SAW/ DRILL-REAMER. This device is classified as a Saw, Pneumatically Powered (Class I - General Controls, product code KFK).
Submitted by Micro-Aire Surgical Instruments, Inc. (San Fernando, US). The FDA issued a Cleared decision on February 24, 1987, 42 days after receiving the submission on January 13, 1987.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4820.
| 510(k) Number | K870157 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 13, 1987 |
| Decision Date | February 24, 1987 |
| Days to Decision | 42 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | — |
| Product Code | KFK — Saw, Pneumatically Powered |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 878.4820 |