The following data is part of a premarket notification filed by Galil Medical Ltd. with the FDA for Icesphere 1.5 Cx Cryoablation Needle.
| Device ID | K181741 |
| 510k Number | K181741 |
| Device Name: | IceSphere 1.5 CX Cryoablation Needle |
| Classification | Unit, Cryosurgical, Accessories |
| Applicant | Galil Medical Ltd. Tavor 1 Building, Industrial Park, PO Box 224 Yokneam, IL 2069203 |
| Contact | Stacey Backlund |
| Correspondent | Stacey Bucklund 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 | 2018-07-02 |
| Decision Date | 2018-07-30 |
| Summary: | summary |