The following data is part of a premarket notification filed by Galil Medical Inc. with the FDA for Icefx Cryoablation System.
| Device ID | K181153 |
| 510k Number | K181153 |
| Device Name: | ICEfx Cryoablation System |
| Classification | Unit, Cryosurgical, Accessories |
| Applicant | Galil Medical Inc. 4364 Round Lake Road Arden Hills, MN 55112 |
| Contact | Rachel Owens |
| Correspondent | Rachel Owens Galil Medical Inc. 4364 Round Lake Road Arden Hills, MN 55112 |
| Product Code | GEH |
| CFR Regulation Number | 878.4350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-05-01 |
| Decision Date | 2018-05-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00859019006387 | K181153 | 000 |
| 00859019006370 | K181153 | 000 |