510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K163236Substantially Equivalent

COOLIEF Cooled Radiofrequency Kit

Halyard Health, Alpharetta GA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K163236 is the FDA 510(k) clearance record for COOLIEF Cooled Radiofrequency Kit, a class II device, cleared for Halyard Health, Inc. on under FDA product code GXI (Probe, Radiofrequency Lesion). FDA records list 96 510(k) clearances for Halyard Health, Inc., from to . As of , FDA records show no recalls naming K163236.

Clearance record

Decision date
Received
(29 days to decision)
Product code
GXI Probe, Radiofrequency Lesion
Regulation
21 CFR 882.4725
Device class
Class II
Review panel
Neurology
Applicant
Halyard Health, Inc. 5405 Windward Pkwy., Alpharetta GA
510(k) summary
Summary PDF
Third party review
Yes

Clearances, product code GXI

Trailing 12 months
2 clearances under product code GXI in the twelve months to October 2026, February 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code GXI, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20261
March 20260
April 20261
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260