Disposable Monopolar Needle Electrode

FDA 510(k) K912783 · Class A Ent.

Substantially Equivalent

510(k) numberK912783

Submission

Device name
Disposable Monopolar Needle Electrode
Applicant
Class A Ent.
Yucca Valley, CA, US
Received
June 24, 1991
Decision date
February 5, 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
GXZ – Electrode, Needle
Device class
Class II (moderate risk)
Regulation
21 CFR 882.1350
Specialty
Neurology

Other 510(k)s with product code GXZ

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K241045Disposable Subdermal Needle Electrode, CorkscrewGXZ · Traditional Technomed Europe12/11/2024SE
K232581Medical Disposable Sterile Needle ElectrodeGXZ · Traditional Suzhou Haishen Medical Device Associates Co., Ltd.12/04/2023SE
K231691Phantom XL Insulated DilatorsGXZ · Special TeDan Surgical Innovations, Inc.06/29/2023SE
K200984Guardian Needle ElectrodeGXZ · Special Rhythmlink International, LLC05/27/2020SE
K192603Spes Medica Subdermal Needle ElectrodesGXZ · Traditional Spes Medica Srl11/22/2019SE
K190801PressOn Electrode HeadsetGXZ · Traditional Rhythmlink International, LLC07/10/2019SE
K161566DMS Disposable Subdermal Needle ElectrodesGXZ · Traditional Daehan Medical Systems Co., Ltd.12/21/2016SE
K142470E-Shield Multi-paried Subdermal Needle ElectrodesGXZ · Special Neuroinvent, Inc.11/05/2014SE
K140200E-Shield Multi-Paired Subdermal Needle ElectrodesGXZ · Traditional Neuroinvent, Inc.07/18/2014SE
K130220MR Conditional Presson ElectrodeGXZ · Traditional Rhythmlink International, LLC07/22/2013SE

More from Rhythmlink International, LLC

510(k)DeviceDecision
K021118Detachable Monopolar Emg Needle, Models 610-725, 610-737, 610-637, 610-744, 610-650…GXZ · Special 05/28/2002SE
K982053EEG Electrodes Model 445 SeriesGXY · Traditional 04/20/1999SE

Questions and answers

When was Disposable Monopolar Needle Electrode cleared by the FDA?

Disposable Monopolar Needle Electrode (K912783) received a 510(k) decision of Substantially Equivalent on February 5, 1992, 226 days after the submission was received.

What is the product code of K912783?

The FDA product code is GXZ – Electrode, Needle, a Class II (moderate risk) device regulated under 21 CFR 882.1350.