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FDA 510(k)

EndoClot

K-Number: K190677 · 2021-01-29

ApplicantEndoclot Plus Co., Ltd.
Decision Date2021-01-29
Product CodeQAU
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

EndoClot is a medical device manufactured by Endoclot Plus Co., Ltd.. It received FDA 510(k) clearance on 2021-01-29 under approval number K190677. The device is classified under product code QAU. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EndoClot?

EndoClot is a medical device that received FDA 510(k) clearance on 2021-01-29. It is manufactured by Endoclot Plus Co., Ltd.. The 510(k) number is K190677.

When was EndoClot approved by the FDA?

EndoClot received FDA 510(k) clearance on 2021-01-29, under approval number K190677.

What company makes EndoClot?

EndoClot is manufactured by Endoclot Plus Co., Ltd..

What is the FDA product code for EndoClot?

The FDA product code for EndoClot is QAU.

Other Devices by Endoclot Plus Co., Ltd.

K162197EndoClot K191254EndoClot

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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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