K243487 is an FDA 510(k) clearance for the CryoFreeze Wart and Skin Tag Remover, a Unit, Cryosurgical, Accessories (Class II — Special Controls, product code GEH), submitted by Cryosurgery, Inc. (Nashville, US). The FDA issued a Cleared decision on March 13, 2025, 125 days after receiving the submission on November 8, 2024. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4350.
| 510(k) Number | K243487 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | November 08, 2024 |
| Decision Date | March 13, 2025 |
| Days to Decision | 125 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 |