The following data is part of a premarket notification filed by Galil Medical Ltd. with the FDA for Icerod Plus 17g Cryoablation Needle, Icerod Plus 17g 90* Cryoablation Needle.
| Device ID | K110946 |
| 510k Number | K110946 |
| Device Name: | ICEROD PLUS 17G CRYOABLATION NEEDLE, ICEROD PLUS 17G 90* CRYOABLATION NEEDLE |
| Classification | Unit, Cryosurgical, Accessories |
| Applicant | GALIL MEDICAL LTD. YOKNEAM GATE, 1 TAVOR BLDG. Yokneam, IL 20692 |
| Contact | Lynne Davies |
| Correspondent | Lynne Davies GALIL MEDICAL LTD. YOKNEAM GATE, 1 TAVOR BLDG. Yokneam, IL 20692 |
| Product Code | GEH |
| CFR Regulation Number | 878.4350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-04-04 |
| Decision Date | 2011-06-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07290104830570 | K110946 | 000 |
| 07290104830563 | K110946 | 000 |