# K081207: Intuitive Surgical DA Vinci S Surgical System, Model IS2000, with DA Vinci Connect and Onsite

- Pathway: 510(k) (Traditional)
- Applicant: Intuitive Surgical, Inc.
- Decided: Dec 19, 2008 after 234 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: 10 generations back to K930667 (1994). 44 ancestors in all.
7 later devices descend from it; 3 cite it directly.
0 of 52 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K050369: Intuitive Surgical DA Vinci Surgical System, Model IS2000, Intuitive Surgical, Inc. (2005) Summary page 1.
- K063220: DA Vinci S Surgical System-V1.1, Model IS2000, Intuitive Surgical, Inc. (2006) Summary page 1.

## Most influential descendants
- K101581: Intuitive Surgical DA Vinci S Surgical System with DA Vinci Connect & DA Vinci Onsite, Model IS2000 (2011), 6 descendants of its own
- K123329: DA Vinvi Surgical System (2014), 3 descendants of its own
- K210478: 8mm Monopolar Curved Scissors (2022), 0 descendants of its own
- K173415: EndoWrist 5mm Thoracic Grasper (2018), 0 descendants of its own
- K170641: da Vinci S/Si Endoscopes, da Vinci Xi Endoscopes (2017), 0 descendants of its own

## Indications for use
The da Vinci Connect is an accessory to the da Vinci S Surgical System and is intended for use by trained Surgical proctors to communicate and to provide surgical advice to the operating surgeon when using the da Vinci S Surgical System, Model IS2000. In addition, the Remote Proctor Interface can be used to view surgical procedures related to the use of the da Vinci S Surgical System, Model IS2000. The da Vinci OnSite is an accessory to the da Vinci S Surgical System and is intended for use by trained Intuitive Surgical Customer Service personnel to obtain da Vinci S Surgical System information for the purpose of diagnosing faults with the da Vinci S Surgical System, Model IS2000.

Source page: https://510kreport.com/device/K081207
Methodology: https://510kreport.com/methodology