K924114 is an FDA 510(k) clearance for the HISTOFREEZER, a Unit, Cryosurgical, Accessories (Class II — Special Controls, product code GEH), submitted by Solarcare Technologies Corp,Inc. (Bethlehem, US). The FDA issued a Cleared decision on February 5, 1993, 184 days after receiving the submission on August 5, 1992. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4350.
| 510(k) Number | K924114 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | August 05, 1992 |
| Decision Date | February 05, 1993 |
| Days to Decision | 184 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Statement |
| Product Code | GEH — Unit, Cryosurgical, Accessories |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 878.4350 |