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Smith & Nephew Instrument Trays

by Smith & Nephew, Inc. 2 variants

510(k) K090562

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK090562 Date18 Mar 2009ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
KCT
Device Class
Class II
Regulation
21 CFR Part 880.6850
Advisory Committee
General Hospital
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 22 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

Smith & Nephew Instrument Trays are designed to contain and protect reusable surgical instruments during processing, sterilization, and storage. They allow optimal exposure of the tray's contents to sterilant during the sterilization process.

These trays are supplied non-sterile and are intended for reuse after appropriate cleaning and sterilization. They are used in general hospital settings and are authorized under FDA 510(k) clearance K090562 with product code KCT product code.

Other devices from Smith & Nephew, Inc.

See all devices from Smith & Nephew, Inc. →

Questions

AI-generated answers, 22 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Smith & Nephew Instrument Tray used for?

    The Smith & Nephew Instrument Tray is designed to contain and protect reusable surgical instruments during processing, sterilization, and storage, allowing optimal exposure to sterilant during the sterilization process in general hospital settings.

  • Is the Smith & Nephew Instrument Tray supplied sterile or non-sterile?

    The Smith & Nephew Instrument Tray is supplied non-sterile and is intended for reuse after appropriate cleaning and sterilization by the healthcare facility.

  • Can the Smith & Nephew Instrument Tray be reused after sterilization?

    Yes, the Smith & Nephew Instrument Tray is designed for reuse following proper cleaning and sterilization procedures, as it is intended to contain and protect reusable surgical instruments over multiple use cycles.

  • What regulatory authorization covers the Smith & Nephew Instrument Tray?

    The Smith & Nephew Instrument Tray is authorized under FDA 510(k) clearance K090562 with product code KCT, indicating it was found substantially equivalent to a legally marketed predicate device.

  • In what type of healthcare setting are Smith & Nephew Instrument Trays intended to be used?

    Smith & Nephew Instrument Trays are intended for use in general hospital settings, where they support the containment, protection, and sterilization of reusable surgical instruments.