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FDA 510(k)

Endo Keeper

K-Number: K152598 · 2016-03-17

ApplicantNelis
Decision Date2016-03-17
Product CodeOTJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Endo Keeper is the device name listed in this FDA 510(k) record. The listed applicant is Nelis. It received FDA 510(k) clearance on 2016-03-17 under 510(k) number K152598. The device is classified under product code OTJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Endo Keeper?

Endo Keeper is a medical device that received FDA 510(k) clearance on 2016-03-17. The listed applicant is Nelis. The 510(k) number is K152598.

When did Endo Keeper receive FDA 510(k) clearance?

Endo Keeper received FDA 510(k) clearance on 2016-03-17, under 510(k) number K152598.

Who is the listed applicant for Endo Keeper?

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

What is the FDA product code for Endo Keeper?

The FDA product code for Endo Keeper is OTJ.

Related Devices (Code: OTJ)

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

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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