# K131962: DA Vinci SP Surgical System, Endowrist SP Instruments, and Accessories

- Pathway: 510(k) (Traditional)
- Applicant: Intuitive Surgical, Inc.
- Decided: Apr 17, 2014 after 294 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: 14 generations back to K930667 (1994). 90 ancestors in all.
22 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)
- K112208: Intutive Surgical DA Vinci Single Site Instruments and Accessories, Intuitive Surgical, Inc. (2011)
- K122532: DA Vinci Single-Site Instruments and Accessories, Intuitive Surgical, Inc. (2013). Cleared while this submission was under review 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) Summary page 1.
- K081137: Intuitive Surgical DA Vinci SI Surgical System: Model IS3000, Intuitive Surgical, Inc. (2009). Our reading of the summary gave K001137, FDA’s number for Aerotrach Plus Valved Holding Chamber (VHC) (Trudell Medical Int'L). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Intuitive Surgical da Vinci Si Surgical System, Model IS3000”.
- K082497: Intuitive Surgical Endowrist One Hot Shears Instrument, Intuitive Surgical, Inc. (2009) Summary page 1.
- K112263: Monopolar Curved Scissors Tip Cover Accessory, Intuitive Surgical, Inc. (2011)
- K123463: Intuitive Surgical DA Vinci SI Surgical System Smartpedals, Intuitive Surgical, Inc. (2012) Summary page 1.

## Most influential descendants
- K173906: da Vinci SP Surgical System, EndoWrist SP Instruments, and Accessories (2018), 21 descendants of its own
- 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

## Indications for use
The Intuitive Surgical Endoscopic Instrument Control System (da Vinci® Sp™ Surgical System, Model 5P999) is intended to assist in the accurate control of Intuitive Surgical Endo Wrist®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 Endo Wrist®Sp™ Instruments are controlled by the da Vinci® Sp™ Surgical System, Model SP999, 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/K131962
Methodology: https://510kreport.com/methodology