# K090993: Intuitive Surgical Endoscopic Instrument Control Systems, Models IS1200, IS2000 and IS3000

- Pathway: 510(k) (Traditional)
- Applicant: Intuitive Surgical, Inc.
- Decided: Dec 16, 2009 after 253 days
- Product code: NAY (System, Surgical, Computer Controlled Instrument)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 11 generations back to K930667 (1994). 52 ancestors in all.
153 later devices descend from it; 20 cite it directly.
1 of 206 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K990144: Intuitive Surgical Endoscopic Instruments, Intuitive Surgical Endoscopic Instrument Control System, Intuitive Surgical, Inc. (2000) Summary page 1.
- K002489: Intuitive Surgical DA Vinci Endoscopic Control System, Intuitive Surgical, Inc. (2001) Summary page 1.
- K011002: Intuitive Surgical DA Vinci Surgical System, Model Isi 1000, Intuitive Surgical, Inc. (2001) Summary page 1.
- K011281: Intuitive Surgical Ultrasonic Shears, Intuitive Surgical, Inc. (2001) Summary page 1.
- K012833: Intuitive Surgical Bipolar Forceps, Intuitive Surgical, Inc. (2001) Summary page 1.
- K013416: Intuitive Surgical Endowrist Endoscopic Instrument Family, Intuitive Surgical, Inc. (2002) Summary page 1.
- K021036: Intuitive Surgical DA Vinci Surgical System, Model IS1000, Intuitive Surgical, Inc. (2002) Summary page 1.
- K022574: Intuitive Surgical Endoscopic Instrument Control System & Endoscopic Instruments, Model DA Vinci Isi 1000/1200, Intuitive Surgical, Inc. (2002) Summary page 1.
- K040237: Intuitive Surgical DA Vinci Endoscopic Instrument Control System and Endoscopic Instruments, Intuitive Surgical, Inc. (2004) Summary page 1.
- K040948: Intuitive Surgical Endopass Endoscopic Delivery Instrument, Model P/N 400170, Intuitive Surgical, Inc. (2004) Summary page 1.
- K042855: Intuitive Surgical Harmonic Curved Shears Instrument, Intuitive Surgical, Inc. (2004) Summary page 1.
- K043153: Intuitive Surgical DA Vinci Surgical System and Endoscopic Instruments, Models IS1200 & IS1000, Intuitive Surgical, Inc. (2004) Summary page 1.
- K043288: Modification to Intuitive Surgical DA Vinci Surgical System and Endoscopic Instruments, Intuitive Surgical, Inc. (2005) Summary page 1.
- K050005: Intuitive Surgical Monopolar Curved Scissors, Model 400179; Tip Cover Accessory, Model 400180, Intuitive Surgical, Inc. (2005) Summary page 1.
- K050369: Intuitive Surgical DA Vinci Surgical System, Model IS2000, Intuitive Surgical, Inc. (2005) 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.
- K060391: Intuitive Surgical Endowrist Stabilizer, Model 420182, Intuitive Surgical, Inc. (2006)
- K061260: Intuitive Surgical Endowrist PK Dissecting Forceps, Models 400214 & 420214, Intuitive Surgical, Inc. (2006) Summary page 1.
- K063220: DA Vinci S Surgical System-V1.1, Model IS2000, Intuitive Surgical, Inc. (2006) Summary page 1.
- K081137: Intuitive Surgical DA Vinci SI Surgical System: Model IS3000, Intuitive Surgical, Inc. (2009). Our reading of the summary gave K001137, FDA’s number for Aerotrach Plus Valved Holding Chamber (VHC) (Trudell Medical Int'L). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Intuitive Surgical da Vinci Surgical Systems (Models IS1200, IS2000…”.

## Most influential descendants
- 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
- K141077: DA Vinci Firefly Imaging System (2014), 87 descendants of its own
- K150956: PINPOINT Endoscopic Fluorescence Imaging System (2016), 70 descendants of its own
- K161792: PINPOINT Endoscopic Fluorescence Imaging System (2016), 68 descendants of its own

## Recalls of this device
- Jan 24, 2013 · Class II · Z-1424-2013: Change to User Manual to remove one indication for use and amend warnings to emphasize restrictions for use.
- Oct 13, 2011 · Class II · Z-1426-2013: Promotional literature for use of the da Vinci system for thyroidectomy, which had not been approved with a change to the 510(k).
- Jul 5, 2011 · Not classified · Z-2930-2011: Potential failure of the retention component of the Master Tool Manipulator (MTM) of the Intuitive Surgical da Vinci Si Surgical System which could cause uncontrolled movement.

## Indications for use
The Intuitive Surgical Endoscopic Instrument Control Systems (da Vinci, da Vinci S and da Vinci Si Surgical Systems Models IS1200, 1S2000, IS3000) are intended to assist in the accurate control of Intuitive. Surgical Endoscopic EndoWrist Instruments and Accessories including rigid endoscopes, blunt and sharp endoscopic dissectors, scissors, scalpels, ultrasonic/harmonic shears, forceps/pick-ups, needle holders, endloscopic 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, gynecologic laparoscopic surgical procedures, transoral otolaryngology surgical procedures restricted to benign and malignant tumors classified as Ti and T2, general thoracoscopic surgical procedures, and thoracoscopically assisted cardiotomny procedures. The system can also be employed with adjunctive mediastinotomy to perform coronary anastomosis during cardiac revascularization. The system is indicated for adult and pediatric use (except for transoral otolaryngology surgical procedures). 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/K090993
Methodology: https://510kreport.com/methodology