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FDA 510(k)

EndoClot

K-Number: K162197 · 2017-01-18

ApplicantEndoclot Plus Co., Ltd.
Decision Date2017-01-18
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

EndoClot is a medical device manufactured by Endoclot Plus Co., Ltd.. It received FDA 510(k) clearance on 2017-01-18 under approval number K162197. The device is classified under product code GCJ. It was reviewed by the GU 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 2017-01-18. It is manufactured by Endoclot Plus Co., Ltd.. The 510(k) number is K162197.

When was EndoClot approved by the FDA?

EndoClot received FDA 510(k) clearance on 2017-01-18, under approval number K162197.

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 GCJ.

Other Devices by Endoclot Plus Co., Ltd.

K191254EndoClot K190677EndoClot

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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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