FDA 510(k)

GT5 conductive & abrasive gel

K-Number: K212787 · 2021-11-08

Decision Date2021-11-08

Product CodeGYB

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

GT5 conductive & abrasive gel is a medical device manufactured by Wuhan Greentek Pty , Ltd.. It received FDA 510(k) clearance on 2021-11-08 under approval number K212787. The device is classified under product code GYB. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GT5 conductive & abrasive gel?

GT5 conductive & abrasive gel is a medical device that received FDA 510(k) clearance on 2021-11-08. It is manufactured by Wuhan Greentek Pty , Ltd.. The 510(k) number is K212787.

When was GT5 conductive & abrasive gel approved by the FDA?

GT5 conductive & abrasive gel received FDA 510(k) clearance on 2021-11-08, under approval number K212787.

What company makes GT5 conductive & abrasive gel?

GT5 conductive & abrasive gel is manufactured by Wuhan Greentek Pty , Ltd..

What is the FDA product code for GT5 conductive & abrasive gel?

The FDA product code for GT5 conductive & abrasive gel is GYB.

Other Devices by Wuhan Greentek Pty , Ltd.

K200162Disposable EEG Electrodes (MODEL: DL, E-CAP, FLEX-CAP)

Related Devices (Code: GYB)

K161654NuFACE Gel PrimerCarol Cole Company K161715EndyGelEndymed Medical, Ltd. K190050Tech Dots - Adhesive and conductive gelSpes Medica Srl K200402DR-HO'S Electro Therapy Conductive GelGuangzhou Xinbo Electronic Co., Ltd. K191975Elefix V Paste for EEG & EMGNihon Kohden Corporation K192606SAC2 - Electrode CreamSpes Medica Srl

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.