K201588 is an FDA 510(k) clearance for the CRYOCARE TOUCH System and Accessories, Endocare 1.7mm Round Ice PerCryo Cryoprobe, Short, Round Ice. This device is classified as a Unit, Cryosurgical, Accessories (Class II - Special Controls, product code GEH).
Submitted by Varian Medical Systems, Inc. (Palo Alto, US). The FDA issued a Cleared decision on August 11, 2020, 60 days after receiving the submission on June 12, 2020.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4350.
| 510(k) Number | K201588 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 12, 2020 |
| Decision Date | August 11, 2020 |
| Days to Decision | 60 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | GEH — Unit, Cryosurgical, Accessories |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4350 |