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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 the device name listed in this FDA 510(k) record. The listed applicant is Corneagen, Inc.. It received FDA 510(k) clearance on 2022-02-02 under 510(k) 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. The listed applicant is Corneagen, Inc.. The 510(k) number is K203586.

When did EndoSerter-PL receive FDA 510(k) clearance?

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

Who is the listed applicant for EndoSerter-PL?

The FDA 510(k) record lists Corneagen, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EndoSerter-PL?

The FDA product code for EndoSerter-PL is OTZ.

Other records listing Corneagen, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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.

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