K863549 is an FDA 510(k) clearance for the REUSABLE/DISPOSABLE AUTOPSY KNIFE SET. This device is classified as a Knife, Surgical (Class I - General Controls, product code EMF).
Submitted by Surgipath Medical Industries, Inc. (Grayslake, US). The FDA issued a Cleared decision on September 30, 1986, 18 days after receiving the submission on September 12, 1986.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4800.
| 510(k) Number | K863549 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 12, 1986 |
| Decision Date | September 30, 1986 |
| Days to Decision | 18 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | — |
| Product Code | EMF — Knife, Surgical |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 878.4800 |