K944221 is an FDA 510(k) clearance for the VERRUCA-FREEZE(TM) CRYOSURGICAL DELIVERY SYST, MODIFIED, 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 15, 1994, 122 days after receiving the submission on August 15, 1994. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4350.
| 510(k) Number | K944221 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | August 15, 1994 |
| Decision Date | December 15, 1994 |
| Days to Decision | 122 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 |