The following data is part of a premarket notification filed by Galil Medical Inc. with the FDA for Iceedge 2.4 Cryoablation Needle,iceedge 2.4 Cryoablation Needle Multipack.
| Device ID | K111859 |
| 510k Number | K111859 |
| Device Name: | ICEEDGE 2.4 CRYOABLATION NEEDLE,ICEEDGE 2.4 CRYOABLATION NEEDLE MULTIPACK |
| Classification | Unit, Cryosurgical, Accessories |
| Applicant | GALIL MEDICAL INC. 63 CHICORY CT. Lake Jackson, TX 77566 |
| Contact | Amy Mckinney |
| Correspondent | Amy Mckinney GALIL MEDICAL INC. 63 CHICORY CT. 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 | 2011-06-30 |
| Decision Date | 2011-10-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07290104830594 | K111859 | 000 |