# K022574: Intuitive Surgical Endoscopic Instrument Control System & Endoscopic Instruments, Model DA Vinci Isi 1000/1200

- Pathway: 510(k) (Traditional)
- Applicant: Intuitive Surgical, Inc.
- Decided: Nov 12, 2002 after 102 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: 3 generations back to K930667 (1994). 11 ancestors in all.
260 later devices descend from it; 13 cite it directly.
1 of 272 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K011002: Intuitive Surgical DA Vinci Surgical System, Model Isi 1000, Intuitive Surgical, Inc. (2001)
- K002489: Intuitive Surgical DA Vinci Endoscopic Control System, Intuitive Surgical, Inc. (2001) Summary page 1.
- K990144: Intuitive Surgical Endoscopic Instruments, Intuitive Surgical Endoscopic Instrument Control System, Intuitive Surgical, Inc. (2000) Summary page 1.
- K965001: Intuitive Surgical Monarch Laparoscopic Manipulator, Intuitive Surgical, Inc. (1997) Summary page 1.

## Most influential descendants
- K040237: Intuitive Surgical DA Vinci Endoscopic Instrument Control System and Endoscopic Instruments (2004), 258 descendants of its own
- K043153: Intuitive Surgical DA Vinci Surgical System and Endoscopic Instruments, Models IS1200 & IS1000 (2004), 251 descendants of its own
- K042855: Intuitive Surgical Harmonic Curved Shears Instrument (2004), 235 descendants of its own
- K050005: Intuitive Surgical Monopolar Curved Scissors, Model 400179; Tip Cover Accessory, Model 400180 (2005), 231 descendants of its own
- K050369: Intuitive Surgical DA Vinci Surgical System, Model IS2000 (2005), 230 descendants of its own

## Indications for use
The Intuitive Surgical* Endoscopic Instrument Control System (hereinafter referred to as the "da Vinci* System") is intended to assist in the accurate control of Intuitive Surgical* Endoscopic Instruments including rigid endoscopes, blunt and sharp endoscopic dissectors, scissors, scalpels, 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 and suturing during general laparoscopic surgical procedures, general non-cardiovascular thoracoscopic surgical procedures, and thoracoscopically-assisted cardiotomy procedures. It is intended to be used by trained physicians in an operating room environment in accordance with the representative, specific procedures set forlh in the Instructions for Use.

Source page: https://510kreport.com/device/K022574
Methodology: https://510kreport.com/methodology