The following data is part of a premarket notification filed by Galil Medical Ltd. with the FDA for Icesphere 1.5 90 Cryoblation Needle, Iceshpere 1.5 Cyoblation Needle.
| Device ID | K141485 |
| 510k Number | K141485 |
| Device Name: | ICESPHERE 1.5 90 CRYOBLATION NEEDLE, ICESHPERE 1.5 CYOBLATION NEEDLE |
| Classification | Unit, Cryosurgical, Accessories |
| Applicant | GALIL MEDICAL LTD. 4364 Round Lake Road Arden Hills, MN 55112 |
| Contact | Lynn Davies |
| Correspondent | Lynn Davies GALIL MEDICAL LTD. 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 | 2014-06-05 |
| Decision Date | 2014-07-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07290104830945 | K141485 | 000 |
| 07290104830938 | K141485 | 000 |
| 07290104830556 | K141485 | 000 |