K023487 is an FDA 510(k) clearance for the HISTOFREEZER WART REMOVAL SYSTEM OR OTHER PROPRIETARY NAME, a Unit, Cryosurgical, Accessories (Class II — Special Controls, product code GEH), submitted by OraSure Technologies, Inc. (Bethelehem, US). The FDA issued a Cleared decision on March 20, 2003, 154 days after receiving the submission on October 17, 2002. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4350.
| 510(k) Number | K023487 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | October 17, 2002 |
| Decision Date | March 20, 2003 |
| Days to Decision | 154 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 |