The following data is part of a premarket notification filed by Galil Medical Inc. with the FDA for Heatfx Microwave Ablation System, Heatfx Microwave Ablation System Cart, Heatfx 2.1 Needle, Heatfx 2.1 S Needle, Multi-point Thermal Sensor (mts).
| Device ID | K200061 |
| 510k Number | K200061 |
| Device Name: | HEATfx Microwave Ablation System, HEATfx Microwave Ablation System Cart, HEATfx 2.1 Needle, HEATfx 2.1 S Needle, Multi-Point Thermal Sensor (MTS) |
| Classification | System, Ablation, Microwave And Accessories |
| Applicant | Galil Medical Inc. 4364 Round Lake Road Arden Hills, MN 55112 |
| Contact | Amy Mckinney |
| Correspondent | Amy Mckinney Galil Medical Inc. 4364 Round Lake Road Arden Hills, MN 55112 |
| Product Code | NEY |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-01-13 |
| Decision Date | 2020-07-09 |