510(k) K212787

GT5 conductive & abrasive gel by Wuhan Greentek Pty , Ltd. — Product Code GYB

K212787 is an FDA 510(k) premarket notification submitted by Wuhan Greentek Pty , Ltd. for the device "GT5 conductive & abrasive gel". The FDA issued a decision of Substantially Equivalent on November 8, 2021. The device falls under product code GYB (Media, Electroconductive), a Class II device regulated under 21 CFR 882.1275. Wuhan Greentek Pty , Ltd. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 8, 2021
Date Received
September 1, 2021
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Media, Electroconductive
Device Class
Class II
Regulation Number
882.1275
Review Panel
NE
Submission Type