# K101581: Intuitive Surgical DA Vinci S Surgical System with DA Vinci Connect & DA Vinci Onsite, Model IS2000

- Pathway: 510(k) (Traditional)
- Applicant: Intuitive Surgical, Inc.
- Decided: Apr 8, 2011 after 305 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: 11 generations back to K930667 (1994). 45 ancestors in all.
6 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)
- K081207: Intuitive Surgical DA Vinci S Surgical System, Model IS2000, with DA Vinci Connect and Onsite, Intuitive Surgical, Inc. (2008) Summary page 1.

## Most influential descendants
- 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
- K123840: Connect for DA Vinci Surgical System (S) (2013), 0 descendants of its own

## Indications for use
The doa Vinci Wireless Connectivity Option is intended to provide a suitable alternative for the wired Ethernet connection between the do Vinci Surgical System and the hospital's Internet Protocol (IP) infrastructure. The Intuitive Surgical Endloscopic Instrument Control System (1S2000 do Vinci S Surgical System with doi Vinci Connecft do Vinci OnSite) Is intended to assist In the accurate control of Intuitive Surgical Endoscopic Instruments including rigid endoscopes, blurt and sharp endoscopic dissectors, scissors, scaipels, ultrasonic shears, forceps/pick-ups, needle holders, endoscopic retractors, stabilizers, electrocautery and accessories for endloscopic manipulation of tissue, including grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery, suturing, and delivery and placement of microwave and cryogenic ablation probes and accessories during urologic surgical procedures, general laparoscopic surgical procedures, gynecological laparoscopic surgical procedures, transoral otolaryngology surgical procedures restricted to benign and malignant tumors classified as TI and T2, general cardiovascular and non-cardiovascular thoracoscopic surgical procedures, and thoracoscopicolly assisted cardlotomy procedures, The system Is indicated for adult and pediatric use. The system can also be employed, with adjunctive mediastinotomy to perform coronary anastomosis during cardiac revascularization. It Is intended for use by trained physicians In an operating room environment In accordance with the representative specific procedures set forth in the Professional Instructions for Use.

Source page: https://510kreport.com/device/K101581
Methodology: https://510kreport.com/methodology