HEATfx Microwave Ablation System, HEATfx Microwave Ablation System Cart, HEATfx 2.1 Needle, HEATfx 2.1 S Needle, Multi-Point Thermal Sensor (MTS)— 510(k) K200061
Substantially EquivalentGalil Medical, Inc.
FDA 510(k) clearance K200061 for HEATfx Microwave Ablation System, HEATfx Microwave Ablation System Cart, HEATfx 2.1 Needle, HEATfx 2.1 S Needle, Multi-Point Thermal Sensor (MTS), Substantially Equivalent on 2020-07-09. Applicant: Galil Medical, Inc.. Device class: 2.
Clearance details
- Applicant
- Galil Medical, Inc.
- Product code
- Code NEY
- Device class
- Class 2
- Regulation
- 21 CFR 878.4400
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Arden Hills, MN, US
Recent devices under product code NEY
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- K241825 — Microwave Ablation Antennas
More clearances from Galil Medical, Inc.
view all- K203032 — IcePearl 2.1 CX 90° Needle, IcePearl 2.1 CX L 90° Needle, IcePearl 2.1 CX Needle, IceFORCE 2.1 CX 90° Needle, IceFORCE 2.1 CX L 90° Needle, IceFORCE 2.1 CX Needle
- K181153 — ICEfx Cryoablation System
- K173037 — Visual-ICE MRI Cryoblation Console, Visual-ICE MRI Junction Box Assembly, Visual-ICE MRI Mobile Connection Panel
- K143564 — Visual-ICE Cryoablation System, Software Revision 1.3.1
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Adverse events under product code NEY
product code NEY- Death
- 24
- Injury
- 388
- Malfunction
- 462
- Other
- 1
- Total
- 875
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.