Model #510 Stealth-Plate Dispersive Electrode

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K922064 ↗

FDA Product Code

GXD

Device Class

Class II

Regulation

21 CFR Part 882.4400

Advisory Committee

Neurology

FDA Decision

SESE Substantially Equivalent

• Traid-Ep, Plate Input, W/Pulse Blanking Circuitry

  Class II

  FDA 510(k) K883304 Active Cleared 9 Nov 1988

• Triad-Ep II, Pushbutton, Cable Input

  Class II

  FDA 510(k) K884532 Active Cleared 18 Nov 1988

• Model 205 Shock-Trode

  Class II

  FDA 510(k) K910661 Active Cleared 2 May 1991

• Model #810 Stealth-Stim Adult Stimulation Pads

  Class II

  FDA 510(k) K913226 Active Cleared 4 Sep 1991

• Model #100 Shock-Trode Child Defib Pads

  Class II

  FDA 510(k) K911455 Active Cleared 16 Oct 1991

• Model #825 Adult Stim. Pads Polymer Type

  Class II

  FDA 510(k) K882337 Active Cleared 2 Aug 1988

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• What is the Model #510 Stealth-Plate Dispersive Electrode used for?

  The Model #510 Stealth-Plate Dispersive Electrode is a medical device designed for use as a dispersive electrode in radiofrequency applications specifically for neurology procedures. It functions as part of a generator system for creating radiofrequency lesions.

• What is the regulatory status of the Model #510 Stealth-Plate Dispersive Electrode?

  The device is authorized under FDA 510(k) clearance with number K922064. It is classified as a Class II device and was determined to be substantially equivalent to other devices in its category for neurology procedures.

• Is the Model #510 Stealth-Plate Dispersive Electrode single-use or reusable?

  The device data does not specify whether the Model #510 Stealth-Plate Dispersive Electrode is designed for single-use or multiple uses. No information regarding sterility or reuse status is provided in the available documentation.

• What sizes or models of the Stealth-Plate Dispersive Electrode are available?

  The available data does not provide information about different sizes or models of the Stealth-Plate Dispersive Electrode. The only model mentioned is the Model #510, and no variations in size or specifications are documented.