510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K922064Substantially Equivalent

Model #510 Stealth-Plate Dispersive Electrode

Cardiotronics, Inc., West Carlsbad CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K922064 is the FDA 510(k) clearance record for MODEL #510 STEALTH-PLATE DISPERSIVE ELECTRODE, a class II device, cleared for Cardiotronics, Inc. on under FDA product code GXD (Generator, Lesion, Radiofrequency). FDA records list 27 510(k) clearances for Cardiotronics, Inc., from to . As of , FDA records show no recalls naming K922064.

Clearance record

Decision date
Received
(211 days to decision)
Product code
GXD Generator, Lesion, Radiofrequency
Regulation
21 CFR 882.4400
Device class
Class II
Review panel
Neurology
Applicant
Cardiotronics, Inc. 2726 Loker Ave., West Carlsbad CA
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