The following data is part of a premarket notification filed by Galil Medical Ltd with the FDA for Icepearl 2.1 Cx Cryoablation Needle, Icepearl 2.1 Cx Prostate Cryoablation Kit Visual-ice System, Iceforce 2.1 Cx Cryoablation Needle, Iceforce 2.1 Cx Prostate Cryoablation Kit Visual-ice System.
| Device ID | K152133 |
| 510k Number | K152133 |
| Device Name: | IcePearl 2.1 CX Cryoablation Needle, IcePearl 2.1 CX Prostate Cryoablation Kit Visual-ICE System, IceFORCE 2.1 CX Cryoablation Needle, IceFORCE 2.1 CX Prostate Cryoablation Kit Visual-ICE System |
| Classification | Unit, Cryosurgical, Accessories |
| Applicant | GALIL MEDICAL LTD TAVOR 1 BUILDING Shaar Yokneam, IL 20692 |
| Contact | Lynne Davies |
| Correspondent | Lynne Davies 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 | 2015-07-31 |
| Decision Date | 2015-08-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07290104831065 | K152133 | 000 |
| 07290104831058 | K152133 | 000 |
| 07290104831041 | K152133 | 000 |
| 07290104831034 | K152133 | 000 |
| 07290104831027 | K152133 | 000 |
| 07290104831010 | K152133 | 000 |
| 07290104831003 | K152133 | 000 |
| 07290104830990 | K152133 | 000 |