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FDA 510(k)

GT5 conductive & abrasive gel

K-Number: K212787 · 2021-11-08

ApplicantWuhan Greentek Pty , Ltd.
Decision Date2021-11-08
Product CodeGYB
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

GT5 conductive & abrasive gel is the device name listed in this FDA 510(k) record. The listed applicant is Wuhan Greentek Pty , Ltd.. It received FDA 510(k) clearance on 2021-11-08 under 510(k) 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. The listed applicant is Wuhan Greentek Pty , Ltd.. The 510(k) number is K212787.

When did GT5 conductive & abrasive gel receive FDA 510(k) clearance?

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

Who is the listed applicant for GT5 conductive & abrasive gel?

The FDA 510(k) record lists Wuhan Greentek Pty , Ltd. as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing Wuhan Greentek Pty , Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Related Devices (Code: GYB)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

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

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