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510(k) K152984

Device
Disposable Concentric Needle Electrodes, Disposable Monopolar Needle Electrodes, Disposable EP Needle Electrodes, Disposable Hypodermic Needle Electrodes
Applicant
BIO PROTECH, INC.
510(k) number
K152984
Product code
IKT  
Decision
Substantially Equivalent (SESE)
Decision date
2016-06-03
Date received
2015-10-09
Regulation
890.1385
Classification name
Electrode, Needle, Diagnostic Electromyograph
Medical specialty
Physical Medicine
Review panel
Neurology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
DANIEL WOO
Address
Donghwa Medical Instrument Complex, 151-3, Donghwagondan-Ro, Munmak-Eup Wonju-Si KR 220-801 220-801

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code IKT  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K253581Disposable Concentric Needle Electrode 0.30x25mm Red (TE/B50700-001); Disposable Concentric Needle Electrode 0.40x25mm Yellow (TE/B50700-002); Disposable Concentric Needle Electrode 0.30x30mm Pink (TE/B50700-006); Disposable Concentric Needle Electrode 0.45x37mm Green (TE/B50700-003); Disposable Concentric Needle Electrode 0.45x50mm Blue (TE/B50700-004); Disposable Concentric Needle Electrode 0.60x75mm Violet (TE/B50700-005)Technomed Europe2026-03-15
K173815Allergan Botox Needle ElectrodeNatus Manufacturing Limited2018-06-29
K161430Myoject Luer Lock Needle ElectrodeNatus Manufacturing Limited2017-03-02
K143433Dantec DCN Disposable Concentric Needle Electrodes-25mm, Dantec DCN Disposable Concentric Needle Electrodes-37mm, Dantec DCN Disposable Concentric Needle Electrodes-50mm, Dantec DCN Disposable Concentric Needle Electrodes-75mmNatus Manufacturing Limited2015-08-28
K120342EMG RECORDING ELECTRODE ASSEMBLYRhythmlink International, LLC2012-06-22
K112034TECA ELITE DISPOSABLE CONCENTRIC NEEDLESCarefusion 209, Inc.2011-08-12
K111131TECA (TM) ELITE DISPOSABLE MONOPOLAR NEEDLESCarefusion 209, Inc.2011-06-17
K092973DISPOSABLE AND REUSABLE CONCENTRIC NEEDLES / DISPOSABLE AND REUSABLE MONOPOLAR NEEDLEBionen S.A.S.2010-10-07
K093825AMBU NEUROLINE DISPOSABLE INOJECT NEEDLE ELECTRODEAmbu A/S2010-01-13
K091410DISPOSABLE EMG NEEDLE ELECTRODES, MYOLINE, MYOLINE 2, MYOBOT,Spes Medica Srl2009-08-11
K091055RHYTHMLINK DISPOSABLE CONCENTRIC EMG NEEDLE, MODEL D039032252RRhythmlink International, LLC2009-06-23
K091056RHYTHMLINK DISPOSABLE MONOPOLAR EMG NEEDLE, MODEL TFDN26032252RRhythmlink International, LLC2009-06-23
K080914ULTRASHARP CONCENTRIC NEEDLESRochester Electro Medical, Inc.2008-07-15
K071186MODIFICATION TO: AMBU NEUROLINE CONCENTRIC NEEDLE ELECTRODEAmbu A/S2007-07-30
K062437DISPOSABLE HYPODERMIC EMG NEEDLE ELECTRODE TECHNOMED EUROPE VERSION AND PRIVATE LABELEDTechnomed Europe2007-02-16

Legacy Summary#

summary

FDA Review#

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