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510(k) K100912

Device
DISPOSABLE NERVE STIMULATING PROBE, BIPOLAR CONCENTRIC, DISPOSABLE NERVE STIMULATOR PROBE, BIPOLAR SIDE BY SIDE
Applicant
KIRWAN SURGICAL PRODUCTS, INC.
510(k) number
K100912
Product code
GXZ  
Decision
Substantially Equivalent (SESE)
Decision date
2010-08-19
Date received
2010-04-01
Regulation
882.1350
Classification name
Electrode, Needle
Medical specialty
Neurology
Review panel
Neurology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
KEVIN P PRARIO
Address
180 Enterprise Dr. Marshfield MA US 02050 02050

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code GXZ  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K241045Disposable Subdermal Needle Electrode, CorkscrewTechnomed Europe2024-12-11
K232581Medical Disposable Sterile Needle ElectrodeSuzhou Haishen Medical Device Associates Co., Ltd.2023-12-04
K231691Phantom XL Insulated DilatorsTeDan Surgical Innovations, Inc.2023-06-29
K200984Guardian Needle ElectrodeRhythmlink International, LLC2020-05-27
K192603Spes Medica Subdermal Needle ElectrodesSpes Medica Srl2019-11-22
K190801PressOn Electrode HeadsetRhythmlink International, LLC2019-07-10
K161566DMS Disposable Subdermal Needle ElectrodesDaehan Medical Systems Co., Ltd.2016-12-21
K142470E-Shield Multi-paried Subdermal Needle ElectrodesNeuroinvent, Inc.2014-11-05
K140200E-SHIELD MULTI-PAIRED SUBDERMAL NEEDLE ELECTRODESNeuroinvent, Inc.2014-07-18
K130220MR CONDITIONAL PRESSON ELECTRODERhythmlink International, LLC2013-07-22
K130136DISPOSABLE AND REUSABLE CONCENTRIC NEEDLE ELECTRODES,DISPOSABLE AND REUSABLE SUBDERMAL NEEDLE ELECTRODES,Technomed Europe2013-07-19
K121347PRESSON ELECTRODERhythmlink International, LLC2012-07-12
K103103PRESSON ELECTRODEPersyst Development Corp.2011-12-08
K110419AVS ARIA NEUROMONITORING PROBE AND AVS ARIA PROBE DILATORSStryker Spine2011-07-28
K073229NERVE MONITORING CABLEPioneer Surgical Technology2008-06-06

Legacy Summary#

summary

FDA Review#

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