K940501 is an FDA 510(k) clearance for the RE-SHARPENABLE SAW BLADES, a Blade, Saw, General & Plastic Surgery, Surgical (Class I — General Controls, product code GFA), submitted by Adven Medical (Plymouth, US). The FDA issued a Cleared decision on June 28, 1994, 146 days after receiving the submission on February 2, 1994. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4820.
| 510(k) Number | K940501 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | February 02, 1994 |
| Decision Date | June 28, 1994 |
| Days to Decision | 146 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | GFA — Blade, Saw, General & Plastic Surgery, Surgical |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 878.4820 |