The following data is part of a premarket notification filed by Galil Medical Inc. with the FDA for Visual-ice Cryoablation System, Software Revision 1.3.1.
| Device ID | K143564 |
| 510k Number | K143564 |
| Device Name: | Visual-ICE Cryoablation System, Software Revision 1.3.1 |
| Classification | Unit, Cryosurgical, Accessories |
| Applicant | GALIL MEDICAL INC. 4264 Round Lake Road Arden Hills, MN 55112 |
| Contact | Amy Mckinney |
| Correspondent | Amy Mckinney GALIL MEDICAL INC. 6518 TAMARIND SKY LN Fulshear, TX 77441 |
| Product Code | GEH |
| CFR Regulation Number | 878.4350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-12-16 |
| Decision Date | 2015-03-05 |
| Summary: | summary |