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 the device name listed in this FDA 510(k) record. The listed applicant is Chengdu Wision Medical Device Co., Ltd.. It received FDA 510(k) clearance on 2021-11-19 under 510(k) 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. The listed applicant is Chengdu Wision Medical Device Co., Ltd.. The 510(k) number is K211326.

When did EndoScreener receive FDA 510(k) clearance?

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

Who is the listed applicant for EndoScreener?

The FDA 510(k) record lists Chengdu Wision Medical Device Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EndoScreener?

The FDA product code for EndoScreener is QNP.

Related Devices (Code: QNP)

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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.