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FDA 510(k)

Signia sterilization tray

K-Number: K161347 · 2016-09-07

ApplicantCovidien
Decision Date2016-09-07
Product CodeKCT
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Signia sterilization tray is a medical device manufactured by Covidien. It received FDA 510(k) clearance on 2016-09-07 under approval number K161347. 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 Signia sterilization tray?

Signia sterilization tray is a medical device that received FDA 510(k) clearance on 2016-09-07. It is manufactured by Covidien. The 510(k) number is K161347.

When was Signia sterilization tray approved by the FDA?

Signia sterilization tray received FDA 510(k) clearance on 2016-09-07, under approval number K161347.

What company makes Signia sterilization tray?

Signia sterilization tray is manufactured by Covidien.

What is the FDA product code for Signia sterilization tray?

The FDA product code for Signia sterilization tray is KCT.

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Related Devices (Code: KCT)

K160574K3PRO SURGICAL TRAYArgon Med. Productions Vertriebs Gesellschaft Mbh CO KG K162600Jewel Precision Reusable Rigid Sterilization Container SystemJewel Precision Sheet Metal & Machine, Inc. K160912Sterilization TraySTERIS Corporation K152745ReNew Sterilization Trays(Catalog #3708 and #3709)Microline Surgical, Inc. K152111Symmetry Surgical Quad-Lock Container SystemSymmetry Surgical, Inc. K152969ENHANCE ALLOGRAFT WEDGE INSTRUMENT TRAYConmed Corporation

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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