# K133942: Endoscope Sterilization Tray

- Pathway: 510(k) (Abbreviated)
- Applicant: Intuitive Surgical
- Decided: Aug 1, 2014 after 221 days
- Product code: KCT (Sterilization Wrap Containers, Trays, Cassettes & Other Accessories)
- Device class: 2
- Regulation: 21 CFR 880.6850
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K013003 (2002). 2 ancestors in all.
19 later devices descend from it; 2 cite it directly.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K103213: Finess Endoscope Sterilization Tray, Entellus Medical, Inc. (2011) Summary page 4.

## Most influential descendants
- K142937: Endoscope Sterilization Tray (2015), 16 descendants of its own
- K151450: Endoscope Sterilization Tray (2016), 15 descendants of its own
- K170640: Endoscope Sterilization Tray (2017), 14 descendants of its own
- K180964: Endoscope Sterilization Tray (2018), 13 descendants of its own
- K183139: Endoscope Sterilization Tray (2019), 12 descendants of its own

## Indications for use
The Intuitive Surgical Endoscope Sterilization Tray is intended for use to encase and protect da Vinci Xi endoscopes (Model #'s 470026 and 470027) for sterilization in the STERRAD 100NX sterilization system using the Express cycle and in the STERRAD 100S sterilization system using the standard cycle. The sterilization cycle parameters of the sterilizers are preset by the manufacturer and are not adjustable. The maximum product load per tray is 1 da Vinci Xi Endoscope. The max weight of tray and endoscope is 7.7 lbs. The Intuitive Surgical Endoscope Sterilization Tray is intended to be used with legally marketed, FDA-cleared STERRAD compatible sterilization wrap in order to maintain sterility of the enclosed endoscope.

Source page: https://510kreport.com/device/K133942
Methodology: https://510kreport.com/methodology