K854858 is an FDA 510(k) clearance for the SCALPEL HANDLE. This device is classified as a Handle, Scalpel (Class I - General Controls, product code GDZ).
Submitted by Medelec Intl. Corp. (Miami Beach, US). The FDA issued a Cleared decision on December 24, 1985, 19 days after receiving the submission on December 5, 1985.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4800.
| 510(k) Number | K854858 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 05, 1985 |
| Decision Date | December 24, 1985 |
| Days to Decision | 19 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | — |
| Product Code | GDZ — Handle, Scalpel |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 878.4800 |