The following data is part of a premarket notification filed by Galil Medical Ltd. with the FDA for Icepearl 2.1 Cx L, Iceforce 2.1 Cx L.
| Device ID | K162599 |
| 510k Number | K162599 |
| Device Name: | IcePearl 2.1 CX L, IceForce 2.1 CX L |
| Classification | Unit, Cryosurgical, Accessories |
| Applicant | GALIL MEDICAL LTD. TAVOR 1 BUILDING, INDUSTRIAL PARK, PO BOX 224 Shaar Yokneam, IL 2069203 |
| 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 | 2016-09-19 |
| Decision Date | 2016-10-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07290104831089 | K162599 | 000 |
| 07290104831072 | K162599 | 000 |