# K050802: Modification to Intuitive Surgical DA Vinci Surgical System and Endoscopic Instruments

- Pathway: 510(k) (Traditional)
- Applicant: Intuitive Surgical, Inc.
- Decided: Jun 29, 2005 after 91 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: 8 generations back to K930667 (1994). 42 ancestors in all.
228 later devices descend from it; 7 cite it directly.
1 of 271 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.
- 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.
- 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). Cleared while this submission was under review Summary page 1.
- K050404: Intuitive Surgical DA Vinci Surgical System and Endoscopic Instruments, Intuitive Surgical, Inc. (2005). Cleared while this submission was under review Summary page 1.

## Most influential descendants
- K063220: DA Vinci S Surgical System-V1.1, Model IS2000 (2006), 224 descendants of its own
- K081137: Intuitive Surgical DA Vinci SI Surgical System: Model IS3000 (2009), 211 descendants of its own
- K060391: Intuitive Surgical Endowrist Stabilizer, Model 420182 (2006), 155 descendants of its own
- K061260: Intuitive Surgical Endowrist PK Dissecting Forceps, Models 400214 & 420214 (2006), 154 descendants of its own
- K090993: Intuitive Surgical Endoscopic Instrument Control Systems, Models IS1200, IS2000 and IS3000 (2009), 153 descendants of its own

## Indications for use
The Intuitive Surgical® da Vinci® Surgical 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, gynecologic laparoscopic surgical procedures, general non-cardiovascular thoracoscopic surgical procedures, and thoracoscopically assisted cardiotomy 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. 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/K050802
Methodology: https://510kreport.com/methodology