K832385 is an FDA 510(k) clearance for the CRYOPROBES MC-1400-CRYOSURG-CONSOLE. This device is classified as a Unit, Cryosurgical, Accessories (Class II - Special Controls, product code GEH).
Submitted by Spembly Medical , Ltd. (Mchenry, US). The FDA issued a Cleared decision on September 12, 1983, 55 days after receiving the submission on July 19, 1983.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4350.
| 510(k) Number | K832385 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 19, 1983 |
| Decision Date | September 12, 1983 |
| Days to Decision | 55 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | — |
| Product Code | GEH — Unit, Cryosurgical, Accessories |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4350 |