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Sonicision Sterilization Tray

by Covidien, Formerly Valleylab, A Division of Tyco H

510(k) K131170

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 · Traditional NumberK131170 Date28 Aug 2013ClearedStatusActive

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  • Withdrawn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, 1 Oct 2026

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

The Sonicision Sterilization Tray is a sterilization wrap container designed to hold and protect surgical instruments, devices, or supplies during sterilization processes. It is classified under the regulatory category for trays, cassettes, and similar accessories used in medical sterilization workflows. Its primary function is to ensure proper containment and sterilization of items prior to use in clinical settings, reducing contamination risks.

This tray is intended for use in general hospital environments and is supplied as a reusable medical device. It is not specified as MRI-safe or single-use in the regulatory submission. The device was cleared through an FDA 510(k) submission (K131170) under the Traditional Review pathway, with a Substantially Equivalent (SESE) determination. No third-party certification or additional regulatory markings are referenced beyond the FDA clearance.

Other devices from Covidien, Formerly Valleylab, A Division of Tyco

Questions

AI-generated answers, 1 Oct 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 Sonicision Sterilization Tray used for?

    The Sonicision Sterilization Tray is designed to hold and protect surgical instruments, devices, or supplies during sterilization processes. Its primary purpose is to ensure proper containment and sterilization of items before they are used in clinical settings, thereby minimizing contamination risks. This makes it ideal for general hospital environments where maintaining sterile conditions is critical.

  • Is the Sonicision Sterilization Tray single-use or reusable?

    The Sonicision Sterilization Tray is supplied as a reusable medical device. Unlike single-use items, this tray is intended to be cleaned, sterilized, and reused multiple times, which helps reduce waste and costs in hospital sterilization workflows.

  • What regulatory pathway was used for the FDA clearance of this device?

    The Sonicision Sterilization Tray was cleared through an FDA 510(k) submission (K131170) under the Traditional Review pathway. The determination made was that it is Substantially Equivalent (SESE) to a legally marketed predicate device, ensuring it meets regulatory standards for safety and effectiveness.

  • Does this tray have any special safety considerations, such as MRI safety?

    The Sonicision Sterilization Tray is not specified as MRI-safe in the regulatory submission. Clinicians should verify compatibility with their specific MRI systems before using this tray in MRI environments. Always follow facility protocols for non-MRI-safe devices.

  • How is the tray classified under regulatory categories?

    The Sonicision Sterilization Tray falls under the regulatory category for trays, cassettes, and similar accessories used in medical sterilization workflows. This classification ensures it aligns with standards for devices intended to protect and sterilize medical instruments in hospital settings.