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FDA 510(k)

Omni Instrument Tray

K-Number: K182052 · 2019-02-26

ApplicantHologic, Inc.
Decision Date2019-02-26
Product CodeKCT
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Omni Instrument Tray is the device name listed in this FDA 510(k) record. The listed applicant is Hologic, Inc.. It received FDA 510(k) clearance on 2019-02-26 under 510(k) number K182052. 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 Omni Instrument Tray?

Omni Instrument Tray is a medical device that received FDA 510(k) clearance on 2019-02-26. The listed applicant is Hologic, Inc.. The 510(k) number is K182052.

When did Omni Instrument Tray receive FDA 510(k) clearance?

Omni Instrument Tray received FDA 510(k) clearance on 2019-02-26, under 510(k) number K182052.

Who is the listed applicant for Omni Instrument Tray?

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

What is the FDA product code for Omni Instrument Tray?

The FDA product code for Omni Instrument Tray is KCT.

Related Clinical Trials

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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

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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