← Back to catalogue

Signia sterilization tray

FDA 510(k)

Class II (US FDA 510(k))

510(k) K161347

by Covidien

Identifiers

510(k) Number
K161347 FDA 510(k)
FDA Product Code
KCT FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 880.6850 FDA 510(k)
Regulation Number
880.6850 FDA 510(k)
Advisory Committee
General Hospital FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Signia Sterilization Tray C2A6503 is a reusable tray designed for holding surgical instruments and accessories during sterilization and transport. It is part of the Signia surgical system and accommodates the Signia handle, adapters, and Tri-Staple reloads. This device is intended for use in general hospital settings, ensuring secure containment of components to maintain sterility and organization. Its design supports efficient workflow by providing a stable platform for processing and transporting instruments.

The Signia Sterilization Tray C2A6503 is supplied as a reusable medical device and is intended for use in hospital sterilization processes. It is compatible with autoclave sterilization methods and must be cleaned and maintained according to standard infection control protocols. The tray is classified under product code KCT and has received FDA 510(k) clearance as substantially equivalent to a predicate device. No specific MRI safety information is provided, and its use is restricted to non-MRI environments unless otherwise validated by the manufacturer.

Frequently asked questions

Is the Signia sterilization tray meant for use in operating rooms or just for sterilization and transport between locations?

The Signia sterilization tray is designed specifically for holding surgical instruments and accessories *during sterilization and transport*, not for direct use in the operating room. Its purpose is to maintain secure containment and sterility of components like the Signia handle, adapters, and Tri-Staple reloads while they undergo autoclave sterilization and are moved between processing and clinical areas. This ensures organized workflows in general hospital settings.

How should I clean and maintain the Signia sterilization tray to ensure it remains safe for reuse?

Since the Signia sterilization tray is a reusable device, it must be cleaned and maintained following standard infection control protocols after each use. The tray is compatible with autoclave sterilization, so it should be processed through this method to ensure proper sterilization. Regular cleaning and maintenance are critical to prevent contamination and ensure its longevity and safe reuse.

Can I use this tray in an MRI environment, or is it restricted to non-MRI areas?

The Signia sterilization tray is explicitly restricted to use in non-MRI environments unless the manufacturer, Covidien, has validated its safety for MRI use. The device data does not provide any specific MRI safety information, so it should not be used in MRI-compatible settings without prior confirmation from the manufacturer.

What types of surgical instruments or accessories can fit inside the Signia sterilization tray?

The Signia sterilization tray is designed to accommodate components of the Signia surgical system, including the Signia handle, adapters, and Tri-Staple reloads. Its design ensures secure containment and organization of these specific items during sterilization and transport, making it ideal for workflows involving these particular surgical tools.

How do I know if this tray is compatible with my hospital’s sterilization processes?

The Signia sterilization tray is explicitly compatible with autoclave sterilization methods, which are standard in most hospital settings. However, to confirm compatibility with your specific sterilization protocols, you should verify that your autoclave settings (temperature, pressure, and cycle type) align with the manufacturer’s guidelines for reusable medical devices. Always follow Covidien’s instructions for cleaning and sterilization to maintain safety and functionality.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Medtronic Signia Sterilization Tray - HealthProductsForYou, Covidien Signia Sterilization Tray for instruments | eBay, Covidien Signia Sterilization Tray SIGTRAY - eBay, For Sale COVIDIEN C2A6503 SIGNIA STERILIZATION TRAY

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Covidien

Sources (1)

  • FDA 510(k) K161347 24 fields · synced Sep 20, 2026