K143564 is an FDA 510(k) clearance for the Visual-ICE Cryoablation System, Software Revision 1.3.1. This device is classified as a Unit, Cryosurgical, Accessories (Class II - Special Controls, product code GEH).
Submitted by Galil Medical, Inc. (Arden Hills, US). The FDA issued a Cleared decision on March 5, 2015, 79 days after receiving the submission on December 16, 2014.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4350.
| 510(k) Number | K143564 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 16, 2014 |
| Decision Date | March 05, 2015 |
| Days to Decision | 79 days |
| Submission Type | Special |
| 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 |