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510(k) K232581

Device
Medical Disposable Sterile Needle Electrode
Applicant
Suzhou Haishen Medical Device Associates Co., Ltd.
510(k) number
K232581
Product code
GXZ
Decision
Substantially Equivalent (SESE)
Decision date
2023-12-04
Date received
2023-08-25
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
Leyi Dai
Address
3f, 4f (Rm. 401, 402), 5f, Bldg. 10, # 168 Majian Rd., Suzhou High-Tech Zone Suzhou CN

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
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
K100912DISPOSABLE NERVE STIMULATING PROBE, BIPOLAR CONCENTRIC, DISPOSABLE NERVE STIMULATOR PROBE, BIPOLAR SIDE BY SIDEKirwan Surgical Products, Inc.2010-08-19
K073229NERVE MONITORING CABLEPioneer Surgical Technology2008-06-06