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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 the device name listed in this FDA 510(k) record. The listed applicant is Ellipse Technologies, Incorporated. It received FDA 510(k) clearance on 2016-01-25 under 510(k) 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. The listed applicant is Ellipse Technologies, Incorporated. The 510(k) number is K151594.

When did Ellipse Supplemental Instrument Trays receive FDA 510(k) clearance?

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

Who is the listed applicant for Ellipse Supplemental Instrument Trays?

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

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

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

Other records listing Ellipse Technologies, Incorporated as applicant

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Related Devices (Code: KCT)

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.

K253187SteriBest® Sterilization Tray SystemMastel SurgicalK260726Straumann® ProClean™ Cassette (041.800 ; 041.801)Institut Straumann AGK252854SteriTite Container System with MediTray ProductsCase Medical, Inc.K253791PUREVUE™ Quick Connect Cannula System Tray; PUREVUE™ Quick Connect Cannula System LidDePuy Mitek, Inc.K251614Stainless Steel Surgical KitsDentsply Sirona, Inc.K251756Sterilization TraysParagon Implant Mfg., LLC

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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