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FDA 510(k)

SONICISION STERILIZATION TRAY

K-Number: K131170 · 2013-08-28

ApplicantCovidien, Formerly Valleylab, A Division of Tyco H
Decision Date2013-08-28
Product CodeKCT
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

SONICISION STERILIZATION TRAY is the device name listed in this FDA 510(k) record. The listed applicant is Covidien, Formerly Valleylab, A Division of Tyco H. It received FDA 510(k) clearance on 2013-08-28 under 510(k) number K131170. 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 SONICISION STERILIZATION TRAY?

SONICISION STERILIZATION TRAY is a medical device that received FDA 510(k) clearance on 2013-08-28. The listed applicant is Covidien, Formerly Valleylab, A Division of Tyco H. The 510(k) number is K131170.

When did SONICISION STERILIZATION TRAY receive FDA 510(k) clearance?

SONICISION STERILIZATION TRAY received FDA 510(k) clearance on 2013-08-28, under 510(k) number K131170.

Who is the listed applicant for SONICISION STERILIZATION TRAY?

The FDA 510(k) record lists Covidien, Formerly Valleylab, A Division of Tyco H as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SONICISION STERILIZATION TRAY?

The FDA product code for SONICISION STERILIZATION TRAY is KCT.

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Other records listing Covidien, Formerly Valleylab, A Division of Tyco H 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.

K253988LiteSet TraysNobel Biocare ABK261935Surgical and Prosthetic TraysDentsply Sirona, Inc.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.

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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