Agram Spyral Electrode

FDA 510(k) K934779 · Agram Export-Import Co.

Substantially Equivalent

510(k) numberK934779

Submission

Device name
Agram Spyral Electrode
Applicant
Agram Export-Import Co.
Glen Rock, NJ, US
Received
October 6, 1993
Decision date
March 14, 1995
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary 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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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

Questions and answers

When was Agram Spyral Electrode cleared by the FDA?

Agram Spyral Electrode (K934779) received a 510(k) decision of Substantially Equivalent on March 14, 1995, 524 days after the submission was received.

What is the product code of K934779?

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