The following data is part of a premarket notification filed by Galil Medical Inc. with the FDA for Visual-ice Cryoablation System.
| Device ID | K123865 |
| 510k Number | K123865 |
| Device Name: | VISUAL-ICE CRYOABLATION SYSTEM |
| Classification | Unit, Cryosurgical, Accessories |
| Applicant | GALIL MEDICAL INC. 6518 TAMARIND SKY LN Fulshear, TX 77441 |
| 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 | 2012-12-17 |
| Decision Date | 2013-02-06 |
| Summary: | summary |