K812388 is an FDA 510(k) clearance for the SURGICAL PAWS. This device is classified as a Clamp, Surgical, General & Plastic Surgery (Class I - General Controls, product code GDJ).
Submitted by Berkeley Medevices (Walker, US). The FDA issued a Cleared decision on November 16, 1981, 88 days after receiving the submission on August 20, 1981.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4800.
| 510(k) Number | K812388 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 20, 1981 |
| Decision Date | November 16, 1981 |
| Days to Decision | 88 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | — |
| Product Code | GDJ — Clamp, Surgical, General & Plastic Surgery |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 878.4800 |