510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K232632Substantially Equivalent

Racz Neurostat RF Generator

Epimed International, Inc., Johnstown NY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K232632 is the FDA 510(k) clearance record for Racz Neurostat RF Generator, a class II device, cleared for Epimed International on under FDA product code GXD (Generator, Lesion, Radiofrequency). FDA records list 16 510(k) clearances for Epimed International, from to . As of , FDA records show no recalls naming K232632.

Clearance record

Decision date
Received
(268 days to decision)
Product code
GXD Generator, Lesion, Radiofrequency
Regulation
21 CFR 882.4400
Device class
Class II
Review panel
Neurology
Applicant
Epimed International 141 Sal Landrio Dr. Crossroads Business Park, Johnstown NY
510(k) summary
Summary PDF
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