K831963 is an FDA 510(k) clearance for the CRYOMEDICS NEUROSTAT. This device is classified as a Device, Surgical, Cryogenic (Class II - Special Controls, product code GXH).
Submitted by Spembly Medical , Ltd. (Walker, US). The FDA issued a Cleared decision on August 12, 1983, 56 days after receiving the submission on June 17, 1983.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.4250.
| 510(k) Number | K831963 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 17, 1983 |
| Decision Date | August 12, 1983 |
| Days to Decision | 56 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | — |
| Product Code | GXH — Device, Surgical, Cryogenic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.4250 |