ClearanceBrief
Panels › Neurology › Product code GXY · Class 2

Electrode, Cutaneous

Regulation 882.1320

12510(k)s in 12 months (441 all time)
0recalls in 12 months (20 all time)
19recalls that name a 510(k)
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Top companies in GXY

DateFirm and productCodeLinked 510(k)
Oct 31, 2023Coapt LLC
Coapt ControlSeal Electrode, cutaneous EMG Electrode
Open, Classified
GXYK223605
Oct 31, 2023Coapt LLC
Coapt Dome Electrode, Gen2 system, cutaneous electrode
Open, Classified
GXYK190416
Aug 26, 2022Mckesson Medical-Surgical Inc. Corporate Office
Cadwell Disposable Ground Electrodes Grounding Pad 1.25 X 1.75 Inch Dimensions, Disposable Model Number: 302288-000
Open, Classified
GXYK933803
Mar 14, 2022Neuralynx Inc
ATLAS Stim Headbox-NK For use only with the ATLAS Neurophysiology System. CAUTION--INVESTIGATIONAL DEVICE Limited by Federal (or United States) law to investigational use. Only for use in Non-Signific
Open, Classified
GXYNone listed
May 9, 2014Medtronic Navigation, Inc.
MOUSE 9732721 STERILE O-ARM 10PK
Terminated
GXYK001284
K012937 +4
May 9, 2014Medtronic Navigation, Inc.
DRAPE 9732722 TUBE STERILE O-ARM 20PK
Terminated
GXYK001284
K012937 +4
Feb 14, 2013NAImco Inc dba Richmar Inc
Foam electrodes with Silver-Carbon construction: P/N 202-9271, Cat No. 400-898, 2" x 2" Electrode, Foam, AG, All Serial Numbers distributed between 11/01/2009 and 01/31/2010 P/N 202-9281, Ca
Terminated
GXYK050469
Feb 14, 2013NAImco Inc dba Richmar Inc
Foam Electrodes with Carbon construction: P/N 201-1261, Cat Nos.: 201-126, 203-678, and 400-856, 1.5" x 3.5" Electrode, Foam, All Serial Numbers distributed between 11/01/2009 and 01/31/2010
Terminated
GXYK050469
Feb 14, 2013NAImco Inc dba Richmar Inc
Cloth electrodes with Silver-Carbon construction: P/N 202-9231, Cat No. 400-899, 2" x 2" Electrode, Cloth, AG, All Serial Numbers distributed between 11/01/2009 and 01/31/2010 P/N 202-9241,
Terminated
GXYK050469
Feb 14, 2013NAImco Inc dba Richmar Inc
Cloth electrodes with Carbon construction: P/N 201-1231, Cat Nos.: 201-123, 202-454, 203-118, 203-342, 203-454, 203-493, 203-672, 400-877, and 400-877-BJC, 2" x 2" Electrode, Cloth, All Se
Terminated
GXYK050469
Dec 10, 2012Covidien LLC dba Uni-Patch
Empi STIMC RE Self Adhesive electrodes. For use on TENS, NMES, FES. a DJO brand A cutaneous electrode is an electrode that is applied directly to a patient's skin either to record physiological s
Terminated
GXYK902195
Dec 10, 2012Covidien LLC dba Uni-Patch
Performa reusable and self-adhering TENS/NMES/FES stimulating electrodes, A cutaneous electrode is an electrode that is applied directly to a patient's skin either to record physiological signals (e
Terminated
GXYK915333
Dec 10, 2012Covidien LLC dba Uni-Patch
Reusable, Self-Adhering TENS/NMES/FES electrodes Single Patient Use Only. An electrocardiograph electrode is the electrical conductor which is applied to the surface of the body to transmit the ele
Terminated
GXYK900519
Dec 10, 2012Covidien LLC dba Uni-Patch
Reusable, non-sterile, self-adhering electrodes for use with TENS/NMES, . Made in the U.S.A. Cutaneous electrode is an electrode that is applied directly to a patient's skin either to record physiol
Terminated
GXYK901575
Jan 26, 2012Nellcor Puritan Bennett Inc. (dba Covidien LP)
BIS Bilateral Sensors, part number 186-0212, packaged in boxes of 10. For use with BIS Monitoring System, Labeled as either Covidien Llc, or Aspect Medical Systems, Inc. Product Usage: To enable rec
Terminated
GXYK062692
Aug 1, 2011Axiobionics, LLC
AxioBionics Wearable Therapy BioVest/Unitard that includes 2-16 BioGel Velcro Electrodes in sizes: 2"x2", 2"x2.5", 2"x3", 2"x3.5", 2"x4", 2"x5", 2"x6", 2"x8", 1.5"x3", 1.5"x5", 1.5"x6", and 1"x1.5".
Terminated
GXYK944543
Aug 1, 2011Axiobionics, LLC
AxioBionics Wearable Therapy BioShorts that includes 2-16 BioGel Velcro Electrodes in sizes: 2"x2", 2"x2.5", 2"x3", 2"x3.5", 2"x4", 2"x5", 2"x6", 2"x8", 1.5"x3", 1.5"x5", 1.5"x6", and 1"x1.5". Cutane
Terminated
GXYK944543
Aug 1, 2011Axiobionics, LLC
AxioBionics Wearable TherapyFreeStep Sleeve (Right and Left) that includes 2-16 BioGel Velcro Electrodes in sizes: 2"x2", 2"x2.5", 2"x3", 2"x3.5", 2"x4", 2"x5", 2"x6", 2"x8", 1.5"x3", 1.5"x5", 1.5"x6"
Terminated
GXYK944543
Aug 1, 2011Axiobionics, LLC
AxioBionics Wearable Therapy Upper Extremity BioSleeve (Right and Left) that includes 2-16 BioGel Velcro Electrodes in sizes: 2"x2", 2"x2.5", 2"x3", 2"x3.5", 2"x4", 2"x5", 2"x6", 2"x8", 1.5"x3", 1.5"x
Terminated
GXYK944543
May 17, 2010International Rehabilitative Sciences, Inc.
The "RS-FBG Full Back Conductive Garment" with electrode attachments for use with interferential and muscle stimulation with a Transcutaneous Electrical Nerve Stimulation device (TENS) and/or muscle s
Terminated
GXYK090951

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