FDA 510(k)

Ellipse Supplemental Instrument Trays

K-Number: K151594 · 2016-01-25

ApplicantEllipse Technologies, Incorporated

Decision Date2016-01-25

Product CodeKCT

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

Ellipse Supplemental Instrument Trays is a medical device manufactured by Ellipse Technologies, Incorporated. It received FDA 510(k) clearance on 2016-01-25 under approval number K151594. The device is classified under product code KCT. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Ellipse Supplemental Instrument Trays?

Ellipse Supplemental Instrument Trays is a medical device that received FDA 510(k) clearance on 2016-01-25. It is manufactured by Ellipse Technologies, Incorporated. The 510(k) number is K151594.

When was Ellipse Supplemental Instrument Trays approved by the FDA?

Ellipse Supplemental Instrument Trays received FDA 510(k) clearance on 2016-01-25, under approval number K151594.

What company makes Ellipse Supplemental Instrument Trays?

Ellipse Supplemental Instrument Trays is manufactured by Ellipse Technologies, Incorporated.

What is the FDA product code for Ellipse Supplemental Instrument Trays?

The FDA product code for Ellipse Supplemental Instrument Trays is KCT.

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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.