# K171294: da Vinci X Surgical System

- Pathway: 510(k) (Special)
- Applicant: Intuitive Surgical, Inc.
- Decided: May 26, 2017 after 24 days
- Product code: NAY (System, Surgical, Computer Controlled Instrument)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: 10 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 14 generations back to K930667 (1994). 55 ancestors in all.
31 later devices descend from it; 16 cite it directly.
1 of 87 devices in its family (counting itself) has 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 4.

## Most influential descendants
- K171632: da Vinci Xi Surgical System (2017), 20 descendants of its own
- K173585: da Vinci Xi Surgical System, da Vinci X Surgical System (2018), 18 descendants of its own
- K173842: da Vinci Xi Surgical System, da Vinci X Surgical System (2018), 18 descendants of its own
- K172643: da Vinci Xi Surgical System; da Vinci X Surgical System (2018), 18 descendants of its own
- K182140: da Vinci Xi Surgical System, da Vinci X Surgical System (2018), 17 descendants of its own

## Recalls of this device
- Apr 2, 2026 · Class II · Z-2046-2026: Due to manipulator containing screws with in the arm sub-assembly that my be susceptible to breaking.
- Nov 7, 2025 · Class II · Z-1232-2026: Due to a software implementation error that allowed instruments arms failing an important diagnostic test to remain in clinical use. This test was supposed to be used to detect Universal Surgical Mani
- Feb 10, 2023 · Class II · Z-1293-2023: Due to Universal Surgical Manipulator (USM) instrument carriage being loose as a result of the linear rail component not being manufactured within specifications.
- Jan 24, 2023 · Class II · Z-1262-2023: Preventative maintenance data was used to identify instrument Arms, part of surgical systems, that allow surgeons to perform surgical tasks, that may be at risk of insertion ballscrew failure, allowin
- Sep 20, 2022 · Class II · Z-0133-2023: Inadvertent energy delivery from surgical system instrument if 1) Force bipolar and bipolar instruments installed on system 2) Force bipolar connected to Force Triad generator, bipolar not connected t
- Jul 26, 2019 · Class II · Z-0926-2020: The firm become aware of a potentially defective capacitors on circuit boards installed on certain da Vinci Xi, X and SP system Vision Side Carts (VSC) and/or Patient Side Carts (PSC). As a result, yo
- Apr 11, 2019 · Class II · Z-1897-2020: Failure of Universal Surgical Manipulators due to a high friction points, resulting in an increase of arm movement to include: feelings of resistance, hesitation, and jerking.
- Nov 21, 2018 · Class II · Z-1961-2020: Due to a manufacturing variation in the arm that can result in a persistent recoverable fault error (error 23087) and loss of arm functionality prior or during surgery.
- Jul 16, 2018 · Class II · Z-3254-2018: Certain Redundant Medical Grade Power Supply (RMGPS) units specific to Surgeon Console and Patient Side Carts were manufactured incorrectly and may fail prior or during use.
- Mar 7, 2018 · Class II · Z-2341-2018: Specific da Vinci X Surgical Systems (IS4200) were shipped with defective Arm Controller Joint (ACJ) boards that were found to have a high rate of failure due to a defective component.

## Indications for use
The Intuitive Surgical Endoscopic Instrument Control System (da Vinci X Surgical System, Model 184200) 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/K171294
Methodology: https://510kreport.com/methodology