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FDA 510(k)

Decanting Device

K-Number: K182819 · 2019-12-02

ApplicantGcmedica Enterprise Ltd.(Wuxi)
Decision Date2019-12-02
Product CodeLHI
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Decanting Device is a medical device manufactured by Gcmedica Enterprise Ltd.(Wuxi). It received FDA 510(k) clearance on 2019-12-02 under approval number K182819. The device is classified under product code LHI. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Decanting Device?

Decanting Device is a medical device that received FDA 510(k) clearance on 2019-12-02. It is manufactured by Gcmedica Enterprise Ltd.(Wuxi). The 510(k) number is K182819.

When was Decanting Device approved by the FDA?

Decanting Device received FDA 510(k) clearance on 2019-12-02, under approval number K182819.

What company makes Decanting Device?

Decanting Device is manufactured by Gcmedica Enterprise Ltd.(Wuxi).

What is the FDA product code for Decanting Device?

The FDA product code for Decanting Device is LHI.

Other Devices by Gcmedica Enterprise Ltd.(Wuxi)

K251882Uterine Aspiration Set

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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.

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