← Back to catalogue

Endoscope Sterilization Tray

FDA 510(k)

Class II (US FDA 510(k))

510(k) K133942

by Intuitive Surgical

Identifiers

510(k) Number
K133942 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)

An endoscope sterilization tray is a device designed to organize and protect endoscopes and their accessories during sterilization, transportation, and decontamination processes. It is intended to maintain instrument integrity and support optimal performance and patient safety through proper handling during reprocessing cycles.

The tray is supplied as a reusable instrument protection tray, typically constructed of stainless steel, with dimensions of 640 mm x 390 mm x 80 mm for the 8 mm endoscope model. It has received FDA 510(k) clearance (K133942) and is cleared for use in general hospital settings, supporting a variety of sterilization cycles as validated through testing.

Frequently asked questions

What is the purpose of the Endoscope Sterilization Tray?

The Endoscope Sterilization Tray is designed to organize and protect endoscopes and their accessories during sterilization, transportation, and decontamination processes. It maintains instrument integrity and supports optimal performance and patient safety through proper handling during reprocessing cycles.

What are the specifications of the Endoscope Sterilization Tray?

The tray is a reusable instrument protection tray typically constructed of stainless steel, with dimensions of 640 mm x 390 mm x 80 mm for the 8 mm endoscope model. It is designed to support various sterilization cycles as validated through testing.

Is the Endoscope Sterilization Tray cleared for hospital use?

Yes, the Endoscope Sterilization Tray has received FDA 510(k) clearance (K133942) and is cleared for use in general hospital settings. It is intended to support a variety of sterilization cycles as validated through testing.

How is the Endoscope Sterilization Tray supplied?

The tray is supplied as a reusable instrument protection tray, typically constructed of stainless steel. It is designed to be used multiple times and is intended to maintain instrument integrity throughout its lifespan when properly cared for according to manufacturer instructions.

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: da Vinci Solutions - InstruSafe, Home - InstruSafe, PDF Intuitive Da Vinci X/Xi System Instrument and Accessory Catalog, PDF Intuitive Da Vinci X/Xi System Instrument and ... - Intuitive Surgical

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
Intuitive Surgical

Sources (1)

  • FDA 510(k) K133942 24 fields · synced Sep 23, 2026