Model #510 Stealth-Plate Dispersive Electrode

Q: What is the product code of K922064?

The FDA product code is GXD – Generator, Lesion, Radiofrequency, a Class II (moderate risk) device regulated under 21 CFR 882.4400.

FDA 510(k) K922064 · Cardiotronics, Inc.

Substantially Equivalent

510(k) numberK922064

Submission

Device name: Model #510 Stealth-Plate Dispersive Electrode
Applicant: Cardiotronics, Inc.
West Carlsbad, CA, US
Received: May 4, 1992
Decision date: December 1, 1992
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code: GXD – Generator, Lesion, Radiofrequency
Device class: Class II (moderate risk)
Regulation: 21 CFR 882.4400
Specialty: Neurology

Other 510(k)s with product code GXD

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K251247	GX1 Radiofrequency Generator Kit (RFG-X1-120V); GX1 Radiofrequency Generator Kit…GXD · Traditional	Boston Scientific Neuromodulation Corporation	08/07/2025SE
K242057	COOLIEF* Radiofrequency Generator (CRG-BASIC, CRG-BASIC-R, CRG-ADVANCED, CRG-ADVANCED-R)GXD · Special	Avanos Medical, Inc.	08/14/2024SE
K232632	Racz Neurostat RF GeneratorGXD · Traditional	Epimed International	05/24/2024SE
K231675	OneRF Ablation SystemGXD · Traditional	Neuroone Medical Technologies Corp.	12/06/2023SE
K220122	Apex 6GXD · Traditional	Rf Innovations, Inc.	03/15/2023SE
K203293	Abbott Medical Grounding Pad, model RF-DGP-ISGXD · Traditional	Abbott Medical	01/21/2022SE
K201610	IonicRF GeneratorGXD · Traditional	Abbott Medical	10/21/2020SE
K192491	Coolief Radiofrequency Generator (CRG) SystemGXD · Traditional	Avanos Medical, Inc.	02/21/2020SE
K181864	Polaris RF Ablation SystemGXD · Traditional	Baylis Medical Company, Inc.	01/02/2019SE
K171143	Relievant Medsystems RF GeneratorGXD · Traditional	Relievant Medsystems	08/18/2017SE

More from Relievant Medsystems

510(k)	Device	Decision
K932903	EKG VestDRX · Traditional	02/24/1995SE
K923297	Model #340 Stealth-Trode+LsLDD · Traditional	09/18/1992SE
K922227	Model #225-ST Shock-Trode Adult Defib Pads SterileLDD · Traditional	06/11/1992SE
K922173	Model # 830 ST Adult Stimulation Pads (Sterile)LDD · Traditional	06/11/1992SE
K922172	Model # 230 ST Stealth-Trode Defib Pads (Sterile)LDD · Traditional	06/11/1992SE
K921606	Model #125 Child Stimulation PadsLDD · Traditional	05/26/1992SE
K920086	Shock-Patch Adult Defibrillation PadsLDD · Traditional	02/03/1992SE
K914725	Coordinator, Cable InputDPS · Traditional	11/05/1991SE
K912621	Model #911 Stealth Multi PadsLDD · Traditional	10/16/1991SE
K911456	Model #110 Stealth-Trode Child Defib PadsLDD · Traditional	10/16/1991SE

Questions and answers

When was Model #510 Stealth-Plate Dispersive Electrode cleared by the FDA?

Model #510 Stealth-Plate Dispersive Electrode (K922064) received a 510(k) decision of Substantially Equivalent on December 1, 1992, 211 days after the submission was received.

What is the product code of K922064?

The FDA product code is GXD – Generator, Lesion, Radiofrequency, a Class II (moderate risk) device regulated under 21 CFR 882.4400.