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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 a medical device manufactured by Nelis. It received FDA 510(k) clearance on 2016-03-17 under approval 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. It is manufactured by Nelis. The 510(k) number is K152598.

When was Endo Keeper approved by the FDA?

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

What company makes Endo Keeper?

Endo Keeper is manufactured by Nelis.

What is the FDA product code for Endo Keeper?

The FDA product code for Endo Keeper is OTJ.

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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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