510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K242057Substantially Equivalent

COOLIEF* Radiofrequency Generator (CRG-BASIC, CRG-BASIC-R, CRG-ADVANCED, CRG-ADVANCED-R)

Halyard Health, Alpharetta GA / Special, Substantially Equivalent
FDA source (opens on fda.gov)

K242057 is the FDA 510(k) clearance record for COOLIEF* Radiofrequency Generator (CRG-BASIC, CRG-BASIC-R, CRG-ADVANCED, CRG-ADVANCED-R), a class II device, cleared for Avanos Medical, Inc. on under FDA product code GXD (Generator, Lesion, Radiofrequency). FDA records list 96 510(k) clearances for Halyard Health, from to . As of , FDA records show no recalls naming K242057.

Clearance record

Decision date
Received
(30 days to decision)
Product code
GXD Generator, Lesion, Radiofrequency
Regulation
21 CFR 882.4400
Device class
Class II
Review panel
Neurology
Applicant
Avanos Medical, Inc. 5405 Windward Pkwy., Alpharetta GA
510(k) summary
Statement
Third party review
No

Clearances, product code GXD

Trailing 12 months

FDA records hold no clearances under product code GXD in the trailing twelve months.

FDA records show no clearances under product code GXD in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code GXD, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260