# K240852: da Vinci X Surgical System (IS4200); da Vinci Xi Surgical System (IS4000)

- Pathway: 510(k) (Traditional)
- Applicant: Intuitive Surgical, Inc.
- Decided: Jun 11, 2025 after 440 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: 24 generations back to K930667 (1994). 70 ancestors in all.
No later device cites it as a predicate yet.
0 of 71 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K131861: DA Vinci Surgical System, Endowrist Instruments and Accessories, Intuitive Surgical, Inc. (2014) Summary page 5.
- K152578: da Vinci Surgical System, Model IS4000, Intuitive Surgical, Inc. (2016) Summary page 5.
- K153276: da Vinci Xi Surgical System, Intuitive Surgical, Inc. (2016) Summary page 5.
- K161178: da Vinci Xi Surgical System, Intuitive Surgical, Inc. (2017) Summary page 5.
- K170713: da Vinci Xi Surgical System, Intuitive Surgical, Inc. (2017) Summary page 5.
- K171632: da Vinci Xi Surgical System, Intuitive Surgical, Inc. (2017) Summary page 5.
- K171294: da Vinci X Surgical System, Intuitive Surgical, Inc. (2017) Summary page 5.
- K172643: da Vinci Xi Surgical System; da Vinci X Surgical System, Intuitive Surgical, Inc. (2018) Summary page 5.
- K173842: da Vinci Xi Surgical System, da Vinci X Surgical System, Intuitive Surgical, Inc. (2018) Summary page 5.
- K173585: da Vinci Xi Surgical System, da Vinci X Surgical System, Intuitive Surgical, Inc. (2018) Summary page 5.
- K182140: da Vinci Xi Surgical System, da Vinci X Surgical System, Intuitive Surgical, Inc. (2018) Summary page 5.
- K183086: da Vinci X and Xi Surgical System, Intuitive Surgical, Inc. (2020) Summary page 5.
- K202834: da Vinci Xi Surgical System (IS4000), da Vinci X Surgical System (IS4200), Intuitive Surgical, Inc. (2020) Summary page 5.
- K211784: da Vinci Xi Surgical System (IS4000), da Vinci X Surgical System (IS4200), Intuitive Surgical, Inc. (2021) Summary page 5.
- K223080: da Vinci X Surgical System  (IS4200), da Vinci Xi Surgical System (IS4000), Intuitive Surgical, Inc. (2022) Summary page 5.
- K231224: da Vinci Xi Surgical System (IS4000), da Vinci X Surgical System (IS4200), Intuitive Surgical, Inc. (2023) Summary page 5.

## Indications for use
The Intuitive Surgical Endoscopic Instrument Control System (da Vinci Surgical System, Models: IS4000 and 1S4200) 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, 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 and cryogenic ablation probes and accessories, during urologic surgical procedures, general laparoscopic surgical procedures, gynecologic laparoscopic surgical procedures, general 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 to be used 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/K240852
Methodology: https://510kreport.com/methodology