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FDA 510(k)

ENDOSERTER

K-Number: K090626 · 2011-01-21

ApplicantOcular Systems, Inc.
Decision Date2011-01-21
Product CodeOTZ
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

ENDOSERTER is the device name listed in this FDA 510(k) record. The listed applicant is Ocular Systems, Inc.. It received FDA 510(k) clearance on 2011-01-21 under 510(k) number K090626. 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?

ENDOSERTER is a medical device that received FDA 510(k) clearance on 2011-01-21. The listed applicant is Ocular Systems, Inc.. The 510(k) number is K090626.

When did ENDOSERTER receive FDA 510(k) clearance?

ENDOSERTER received FDA 510(k) clearance on 2011-01-21, under 510(k) number K090626.

Who is the listed applicant for ENDOSERTER?

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

What is the FDA product code for ENDOSERTER?

The FDA product code for ENDOSERTER is OTZ.

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Related Devices (Code: OTZ)

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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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