K183213 is an FDA 510(k) clearance for the IceSense 3, ProSense, MultiSense, a Unit, Cryosurgical, Accessories (Class II — Special Controls, product code GEH), submitted by IceCure Medical , Ltd. (Caesarea, IL). The FDA issued a Cleared decision on December 20, 2019, 396 days after receiving the submission on November 19, 2018. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4350.
| 510(k) Number | K183213 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | November 19, 2018 |
| Decision Date | December 20, 2019 |
| Days to Decision | 396 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 |