The following data is part of a premarket notification filed by Galil Medical Ltd. with the FDA for Icerod Cx Cryoablation Needle Icerod Cx Cryoablation Needle Multipack.
| Device ID | K121251 |
| 510k Number | K121251 |
| Device Name: | ICEROD CX CRYOABLATION NEEDLE ICEROD CX CRYOABLATION NEEDLE MULTIPACK |
| Classification | Unit, Cryosurgical, Accessories |
| Applicant | GALIL MEDICAL LTD. 126 MESQUITE STREET Lake Jackson, TX 77566 |
| Contact | Lynne Davies |
| Correspondent | Lynne Davies GALIL MEDICAL LTD. 126 MESQUITE STREET Lake Jackson, TX 77566 |
| Product Code | GEH |
| CFR Regulation Number | 878.4350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-04-25 |
| Decision Date | 2012-08-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07290104830587 | K121251 | 000 |