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FDA 510(k)

EndoSerter-PL

K-Number: K203586 · 2022-02-02

ApplicantCorneagen, Inc.
Decision Date2022-02-02
Product CodeOTZ
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

EndoSerter-PL is a medical device manufactured by Corneagen, Inc.. It received FDA 510(k) clearance on 2022-02-02 under approval number K203586. The device is classified under product code OTZ. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EndoSerter-PL?

EndoSerter-PL is a medical device that received FDA 510(k) clearance on 2022-02-02. It is manufactured by Corneagen, Inc.. The 510(k) number is K203586.

When was EndoSerter-PL approved by the FDA?

EndoSerter-PL received FDA 510(k) clearance on 2022-02-02, under approval number K203586.

What company makes EndoSerter-PL?

EndoSerter-PL is manufactured by Corneagen, Inc..

What is the FDA product code for EndoSerter-PL?

The FDA product code for EndoSerter-PL is OTZ.

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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