# K180964: Endoscope Sterilization Tray

- Pathway: 510(k) (Traditional)
- Applicant: Intuitive Surgical, Inc.
- Decided: Sep 28, 2018 after 169 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: 6 generations back to K013003 (2002). 6 ancestors in all.
13 later devices descend from it; 1 cites it directly.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K170640: Endoscope Sterilization Tray, Intuitive Surgical, Inc. (2017) Summary page 4.

## Most influential descendants
- K183139: Endoscope Sterilization Tray (2019), 12 descendants of its own
- K232610: da Vinci Surgical System Model IS5000, da Vinci Insufflator and Tube Set with Smoke Evacuation (2024), 11 descendants of its own
- K251739: da Vinci Surgical System (IS5000) (2026), 2 descendants of its own
- K241284: da Vinci Surgical System (IS5000) (2024), 2 descendants of its own
- K251202: da Vinci Surgical System (IS5000) (2025), 1 descendant of its own

## Indications for use
The Intuitive Surgical Endoscope Sterilization Tray is intended for use to encase and protect compatible da Vinci Xi endoscopes for sterilization in any of the following sterilization machines/cycles: * STERRAD 100NX sterilization system using the Express cycle * STERRAD 100S sterilization system using the Standard cycle * Steris V-PRO maX using the Non Lumen, Flexible, or Lumen cycles * Steris V-PRO 1 Plus using the Non Lumen or Lumen cycles * Steris V-PRO 1 using the V-PRO/Lumen cycle The sterilization cycle parameters of the sterilizers are preset by the manufacturers and are not adjustable. The maximum product load per tray is one da Vinci Xi Endoscope. The length of the da Vinci Xi Endoscope is approximately 600 mm and the diameter of the shaft is 8.8 mm. The maximum weight of the tray and endoscope is 8.9 Ibs. The Endoscope Sterilization Tray is not intended to maintain sterility; it is intended to be used in conjunction with a legally marketed, validated, FDA-cleared STERRAD and Steris compatible sterilization wrap in order to maintain sterility of the enclosed medical instrument.

Source page: https://510kreport.com/device/K180964
Methodology: https://510kreport.com/methodology