# K142683: 12 mm Endoscopes and Accessories

- Pathway: 510(k) (Traditional)
- Applicant: Intuitive Surgical, Inc.
- Decided: Dec 10, 2014 after 82 days
- Product code: NAY (System, Surgical, Computer Controlled Instrument)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 14 generations back to K930667 (1994). 59 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 61 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K131861: DA Vinci Surgical System, Endowrist Instruments and Accessories, Intuitive Surgical, Inc. (2014) Summary page 5.
- K140553: Endowrist Stapler 45 and Stapler 45 Reloads, Intuitive Surgical, Inc. (2014) Summary page 5.
- K133942: Endoscope Sterilization Tray, Intuitive Surgical (2014) Summary page 5.

## Most influential descendants
- K251490: 8 mm Assist Cannula; 12 mm Assist Cannula (2025), 0 descendants of its own

## Indications for use
The 12 mm Endoscope is intended to provide real-time, 3D, high-definition imaging enabling surgeons to perform minimally invasive surgery. The Intuitive Surgical 12 mm Endoscope Sterilization Tray is intended for use to encase and protect da Vinei Xi endoscopes (Model #’s 951246 and 951247) for sterilization in any of the following sterilization machines/cycles: * STERRAD 100NX sterilization system using the Express cycle * STERRAD 1008 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 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 maximum weight of tray and endoscope is 11.0 Ibs. The Intuitive Surgical Endoscope Sterilization Tray is intended to be used with legally marketed, FDA-cleared STERRAD and Steris compatible sterilization wrap in order to maintain sterility of the enclosed endoscope.

Source page: https://510kreport.com/device/K142683
Methodology: https://510kreport.com/methodology