The following data is part of a premarket notification filed by Galil Medical Ltd. with the FDA for Icerod Cx Cryoablation Needle.
| Device ID | K140584 |
| 510k Number | K140584 |
| Device Name: | ICEROD CX CRYOABLATION NEEDLE |
| Classification | Unit, Cryosurgical, Accessories |
| Applicant | GALIL MEDICAL LTD. 4364 Round Lake Road Arden Hills, MN 55112 |
| Contact | Lynne Davies |
| Correspondent | Lynne 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 | 2014-03-07 |
| Decision Date | 2014-03-31 |
| Summary: | summary |