# K173906: da Vinci SP Surgical System, EndoWrist SP Instruments, and Accessories

- Pathway: 510(k) (Traditional)
- Applicant: Intuitive Surgical, Inc.
- Decided: May 31, 2018 after 160 days
- Product code: NAY (System, Surgical, Computer Controlled Instrument)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: 9 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 15 generations back to K930667 (1994). 91 ancestors in all.
21 later devices descend from it; 1 cites it directly.
0 of 113 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K131962: DA Vinci SP Surgical System, Endowrist SP Instruments, and Accessories, Intuitive Surgical, Inc. (2014) Summary page 4.

## Most influential descendants
- K182371: da Vinci SP Surgical System, EndoWrist SP Instruments, and Accessories (2019), 20 descendants of its own
- K202571: da Vinci SP Surgical System, Model SP1098, EndoWrist SP Instruments, and Accessories (2020), 14 descendants of its own
- K230033: Da Vinci SP Surgical System (SP1098) (2023), 12 descendants of its own
- K231798: da Vinci SP Surgical System (2023), 11 descendants of its own
- K240502: da Vinci SP Surgical System (SP1098) (2024), 9 descendants of its own

## Recalls of this device
- Apr 22, 2026 · Class II · Z-2521-2026: Operative components of surgical systems potentially distributed with E-brake retainer pin, so in event of a structural column failure, the E-brake pin would prevent E-brake engagement and may result 
- May 12, 2025 · Class II · Z-2722-2026: Robotic-assisted surgical system arm drapes may detach from the instrument arm due to an issue involving the drape rings located at the top of the product, which may expose a section of instrument arm
- Mar 13, 2024 · Class II · Z-1518-2024: Surgical system may have inadequately welded top and/or bottom belts in the link 2 of the entry guide manipulator assembly/instrument arm joints, that may cause the following, 1) Top Failure: internal
- Sep 22, 2021 · Class II · Z-0419-2022: Issue was identified during internal engineering evaluation. Use of the system with the affected software version may experience either an inability to deliver energy or an inadvertent delivery of ene
- Aug 19, 2019 · Class II · Z-2131-2020: Some cameras were found to have residual soil adhered to the tip of the camera after reprocessing which may affect image quality resulting in needing to switch to a second camera or converting to anot
- Jul 26, 2019 · Class II · Z-0927-2020: 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 1, 2019 · Class II · Z-2260-2020: Intuitive has become aware that the da Vinci SP system may trigger a mechanical vibration of the instrument tips and endoscope due to a software anomaly. This issue has the potential to occur only und
- Oct 25, 2018 · Class II · Z-1906-2020: The instrument drape may tear while draping the Patient Side Cart presenting a breach in the sterile barrier.
- Oct 23, 2018 · Class II · Z-0845-2020: The firm became aware of a problem with the surgical system where the cannula mount button may be damaged when the user releases the button abruptly.

## Indications for use
The Intuitive Surgical® Endoscopic Instrument Control System (da Vinci SP® Surgical System, Model SP1098) is intended to assist in the accurate control of Intuitive Surgical EndoWrist SP™ Instruments during urologic surgical procedures that are appropriate for a single port approach. The system is indicated for adult 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. Intuitive Surgical® EndoWrist SP™ Instruments are controlled by the da Vinci SP® Surgical System, Model SP1098, and include flexible endoscopes, blunt and sharp endoscopic dissectors, scissors, 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, and suturing through a single incision laparoscopic approach. The system is indicated for urologic surgical procedures that are appropriate for a single port approach. The system is indicated for adult 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/K173906
Methodology: https://510kreport.com/methodology