510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K200061Substantially Equivalent

HEATfx Microwave Ablation System, HEATfx Microwave Ablation System Cart, HEATfx 2.1 Needle, HEATfx 2.1 S Needle, Multi-Point Thermal Sensor (MTS)

Galil Medical Ltd., Arden Hills MN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K200061 is the FDA 510(k) clearance record for HEATfx Microwave Ablation System, HEATfx Microwave Ablation System Cart, HEATfx 2.1 Needle, HEATfx 2.1 S Needle, Multi-Point Thermal Sensor (MTS), a class II device, cleared for Galil Medical, Inc. on under FDA product code NEY (System, Ablation, Microwave And Accessories). FDA records list 31 510(k) clearances for Galil Medical, Inc., from to . As of , FDA records show no recalls naming K200061.

Clearance record

Decision date
Received
(178 days to decision)
Product code
NEY System, Ablation, Microwave And Accessories
Regulation
21 CFR 878.4400
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Galil Medical, Inc. 4364 Round Lake Rd., Arden Hills MN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code NEY

Trailing 12 months
2 clearances under product code NEY in the twelve months to October 2026, March 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code NEY, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20262
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260