# K182371: da Vinci SP Surgical System, EndoWrist SP Instruments, and Accessories

- Pathway: 510(k) (Traditional)
- Applicant: Intuitive Surgical, Inc.
- Decided: Mar 14, 2019 after 195 days
- Product code: NAY (System, Surgical, Computer Controlled Instrument)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 16 generations back to K930667 (1994). 92 ancestors in all.
20 later devices descend from it; 2 cite 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)
- K173906: da Vinci SP Surgical System, EndoWrist SP Instruments, and Accessories, Intuitive Surgical, Inc. (2018) Summary page 5.
- K090993: Intuitive Surgical Endoscopic Instrument Control Systems, Models IS1200, IS2000 and IS3000, Intuitive Surgical, Inc. (2009) Summary page 5.

## Most influential descendants
- 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
- K242318: da Vinci SP Surgical System (SP1098) (2024), 7 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

## Indications for use
da Vinci SP ® Surgical System, Model SP1098: 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 and transoral otolaryngology surgical procedures in the oropharynx restricted to benign tumors and malignant tumors classified as T1 and T2. 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. EndoWrist SP® Instruments: 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 port. The system is indicated for urologic surgical procedures that are appropriate for a single port approach and transoral otolaryngology surgical procedures in the oropharynx restricted to benign tumors and malignant tumors classified as T1 and T2. 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/K182371
Methodology: https://510kreport.com/methodology