K864425 is an FDA 510(k) clearance for the RAYLOR(TM) DISSECTING HOOK. This device is classified as a Hook, Surgical, General & Plastic Surgery (Class I - General Controls, product code GDG).
Submitted by Cedar Surgical, Inc. (Minnetonka, US). The FDA issued a Cleared decision on December 12, 1986, 32 days after receiving the submission on November 10, 1986.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4800.
| 510(k) Number | K864425 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 10, 1986 |
| Decision Date | December 12, 1986 |
| Days to Decision | 32 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | — |
| Product Code | GDG — Hook, Surgical, General & Plastic Surgery |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 878.4800 |