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FDA 510(k)

EndoScreener

K-Number: K211326 · 2021-11-19

ApplicantChengdu Wision Medical Device Co., Ltd.
Decision Date2021-11-19
Product CodeQNP
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

EndoScreener is a medical device manufactured by Chengdu Wision Medical Device Co., Ltd.. It received FDA 510(k) clearance on 2021-11-19 under approval number K211326. The device is classified under product code QNP. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EndoScreener?

EndoScreener is a medical device that received FDA 510(k) clearance on 2021-11-19. It is manufactured by Chengdu Wision Medical Device Co., Ltd.. The 510(k) number is K211326.

When was EndoScreener approved by the FDA?

EndoScreener received FDA 510(k) clearance on 2021-11-19, under approval number K211326.

What company makes EndoScreener?

EndoScreener is manufactured by Chengdu Wision Medical Device Co., Ltd..

What is the FDA product code for EndoScreener?

The FDA product code for EndoScreener is QNP.

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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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