# K063220: DA Vinci S Surgical System-V1.1, Model IS2000

- Pathway: 510(k) (Traditional)
- Applicant: Intuitive Surgical, Inc.
- Decided: Dec 1, 2006 after 38 days
- Product code: NAY (System, Surgical, Computer Controlled Instrument)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K930667 (1994). 43 ancestors in all.
224 later devices descend from it; 7 cite it directly.
1 of 268 devices in its family (counting itself) has 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.
- K021036: Intuitive Surgical DA Vinci Surgical System, Model IS1000, Intuitive Surgical, Inc. (2002) Summary page 1.
- K050404: Intuitive Surgical DA Vinci Surgical System and Endoscopic Instruments, Intuitive Surgical, Inc. (2005) Summary page 1.
- K050802: Modification to Intuitive Surgical DA Vinci Surgical System and Endoscopic Instruments, Intuitive Surgical, Inc. (2005) Summary page 1.

## Most influential descendants
- K081137: Intuitive Surgical DA Vinci SI Surgical System: Model IS3000 (2009), 211 descendants of its own
- K090993: Intuitive Surgical Endoscopic Instrument Control Systems, Models IS1200, IS2000 and IS3000 (2009), 153 descendants of its own
- K123463: Intuitive Surgical DA Vinci SI Surgical System Smartpedals (2012), 148 descendants of its own
- K131861: DA Vinci Surgical System, Endowrist Instruments and Accessories (2014), 124 descendants of its own
- K101077: DA Vinci Fluorescence Imaging Vision System, Model FF 100 (2011), 104 descendants of its own

## Recalls of this device
- Feb 6, 2012 · Not classified · Z-1202-2012: The holding brake, a component of the da Vinci S Surgical System, may allow passive uncontrolled motion due to gravity during specific power-off conditions.
- Oct 4, 2007 · Not classified · Z-0152-2008: Under-Rated Fuses -- The Firm may have installed incorrect fuses. The daVinci Surgical System Vision Cart's isolation transformer requires a 10A fuse for 115V operation or a 5A fuse for 230V operation
- Oct 4, 2007 · Not classified · Z-0151-2008: Under-Rated Fuses--The Firm may have installed incorrect fuses. The daVinci Surgical System Vision Cart's isolation transformer requires a 10A fuse for 115V operation or a 5A fuse for 230V operation. 
- May 14, 2007 · Not classified · Z-1245-2007: Product may malfunction and fail to start up on AC power.

## Indications for use
The Intuitive Surgical Endoscopic Instrument Control System is intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments including rigid endoscopes, blunt and sharp endoscopic dissectors, scissors, scalpels, ultrasonic shears, forceps/pick-ups, needle holders, endoscopic retractors, stabilizers, electrocautery and accessories for endoscopic manipulation of tissue, including grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery, suturing, and delivery and placement of microwave ablation probes and accessories during urologic surgical procedures, general laparoscopic surgical procedures, gynecological laparoscopic surgical procedures, general non-cardiovascular thoracoscopic surgical procedures, and thoracoscopically assisted cardiotomy 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/K063220
Methodology: https://510kreport.com/methodology