K231661 is an FDA 510(k) clearance for the CryoThin™ Surgical System and Accessories. This device is classified as a Unit, Cryosurgical, Accessories (Class II - Special Controls, product code GEH).
Submitted by Medinux (Tianjin) Technologies Co., Ltd. (Tianjin, CN). The FDA issued a Cleared decision on November 27, 2023, 173 days after receiving the submission on June 7, 2023.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4350.
| 510(k) Number | K231661 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 07, 2023 |
| Decision Date | November 27, 2023 |
| Days to Decision | 173 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 |