510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K901540Substantially Equivalent

Model Rfg-3C Radiofrequency Lesion Generator

Radionics, Inc., Burlington MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K901540 is the FDA 510(k) clearance record for MODEL RFG-3C RADIOFREQUENCY LESION GENERATOR, a class II device, cleared for Radionics, Inc. on under FDA product code GXD (Generator, Lesion, Radiofrequency). FDA records list 57 510(k) clearances for Radionics, Inc., from to . As of , FDA records show no recalls naming K901540.

Clearance record

Decision date
Received
(371 days to decision)
Product code
GXD Generator, Lesion, Radiofrequency
Regulation
21 CFR 882.4400
Device class
Class II
Review panel
Neurology
Applicant
Radionics, Inc. P.O. Box 438, Burlington MA
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 November 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code GXD, trailing twelve months
MonthClearances
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260
November 20260