K243454 is an FDA 510(k) clearance for the Verruca-Freeze H. This device is classified as a Unit, Cryosurgical, Accessories (Class II - Special Controls, product code GEH).
Submitted by Cryosurgery, Inc. (Nashville, US). The FDA issued a Cleared decision on December 3, 2024, 26 days after receiving the submission on November 7, 2024.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4350.
| 510(k) Number | K243454 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 07, 2024 |
| Decision Date | December 03, 2024 |
| Days to Decision | 26 days |
| Submission Type | Special |
| 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 |