# K123329: DA Vinvi Surgical System

- Pathway: 510(k) (Traditional)
- Applicant: Intuitive Surgical, Inc.
- Decided: Sep 17, 2014 after 691 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: 13 generations back to K930667 (1994). 80 ancestors in all.
3 later devices descend from it; 3 cite it directly.
0 of 84 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K990144: Intuitive Surgical Endoscopic Instruments, Intuitive Surgical Endoscopic Instrument Control System, Intuitive Surgical, Inc. (2000) Summary page 4.
- K002489: Intuitive Surgical DA Vinci Endoscopic Control System, Intuitive Surgical, Inc. (2001) Summary page 4.
- K011002: Intuitive Surgical DA Vinci Surgical System, Model Isi 1000, Intuitive Surgical, Inc. (2001) Summary page 4.
- K011281: Intuitive Surgical Ultrasonic Shears, Intuitive Surgical, Inc. (2001) Summary page 4.
- K012833: Intuitive Surgical Bipolar Forceps, Intuitive Surgical, Inc. (2001) Summary page 4.
- K013416: Intuitive Surgical Endowrist Endoscopic Instrument Family, Intuitive Surgical, Inc. (2002) Summary page 4.
- K021036: Intuitive Surgical DA Vinci Surgical System, Model IS1000, Intuitive Surgical, Inc. (2002) Summary page 4.
- K022574: Intuitive Surgical Endoscopic Instrument Control System & Endoscopic Instruments, Model DA Vinci Isi 1000/1200, Intuitive Surgical, Inc. (2002) Summary page 4.
- K040237: Intuitive Surgical DA Vinci Endoscopic Instrument Control System and Endoscopic Instruments, Intuitive Surgical, Inc. (2004) Summary page 4.
- K040948: Intuitive Surgical Endopass Endoscopic Delivery Instrument, Model P/N 400170, Intuitive Surgical, Inc. (2004) Summary page 4.
- K042855: Intuitive Surgical Harmonic Curved Shears Instrument, Intuitive Surgical, Inc. (2004) Summary page 4.
- K043153: Intuitive Surgical DA Vinci Surgical System and Endoscopic Instruments, Models IS1200 & IS1000, Intuitive Surgical, Inc. (2004) Summary page 4.
- K043288: Modification to Intuitive Surgical DA Vinci Surgical System and Endoscopic Instruments, Intuitive Surgical, Inc. (2005) Summary page 4.
- K050005: Intuitive Surgical Monopolar Curved Scissors, Model 400179; Tip Cover Accessory, Model 400180, Intuitive Surgical, Inc. (2005) Summary page 4.
- K050369: Intuitive Surgical DA Vinci Surgical System, Model IS2000, Intuitive Surgical, Inc. (2005) Summary page 4.
- K050404: Intuitive Surgical DA Vinci Surgical System and Endoscopic Instruments, Intuitive Surgical, Inc. (2005) Summary page 4.
- K050802: Modification to Intuitive Surgical DA Vinci Surgical System and Endoscopic Instruments, Intuitive Surgical, Inc. (2005) Summary page 4.
- K060391: Intuitive Surgical Endowrist Stabilizer, Model 420182, Intuitive Surgical, Inc. (2006) Summary page 4.
- K061260: Intuitive Surgical Endowrist PK Dissecting Forceps, Models 400214 & 420214, Intuitive Surgical, Inc. (2006) Summary page 4.
- K063220: DA Vinci S Surgical System-V1.1, Model IS2000, Intuitive Surgical, Inc. (2006) Summary page 4.
- K081137: Intuitive Surgical DA Vinci SI Surgical System: Model IS3000, Intuitive Surgical, Inc. (2009) Summary page 4.
- K090993: Intuitive Surgical Endoscopic Instrument Control Systems, Models IS1200, IS2000 and IS3000, Intuitive Surgical, Inc. (2009) Summary page 4.
- K093217: 5 MM Harmonic Ace Instrument (Used with DA Vinci IS1200 & IS2000/IS3000 System), Intuitive Surgical, Inc. (2010) Summary page 4.
- K101743: 5MM Flared Cannula Model 420262, 8MM Flared Cannula Model 420319, Intuitive Surgical, Inc. (2011) Summary page 4.
- K101581: Intuitive Surgical DA Vinci S Surgical System with DA Vinci Connect & DA Vinci Onsite, Model IS2000, Intuitive Surgical, Inc. (2011) Summary page 4.
- K110451: Endowrist One Suction/Irrigator, Intuitive Surgical, Inc. (2011) Summary page 4.
- K112584: 5MM/8MM Harmonic Ace (TM) Curved Shears, Disposable Harmonic Ace (TM) Insert, Disposable Harmonic (TM) Curved Shears Insert, Intuitive Surgical, Inc. (2011) Summary page 4.
- K112263: Monopolar Curved Scissors Tip Cover Accessory, Intuitive Surgical, Inc. (2011) Summary page 4.
- K110639: Endowrist One Vessel Sealer, Intuitive Surgical, Inc. (2011) Summary page 4.

## Most influential descendants
- K210478: 8mm Monopolar Curved Scissors (2022), 0 descendants of its own
- K173415: EndoWrist 5mm Thoracic Grasper (2018), 0 descendants of its own
- K170641: da Vinci S/Si Endoscopes, da Vinci Xi Endoscopes (2017), 0 descendants of its own

## Indications for use
Transoral otolaryngology surgical procedures restricted to benign and malignant tumors, classified as T1 and T2, and for benign base of tongue resection procedures.

Source page: https://510kreport.com/device/K123329
Methodology: https://510kreport.com/methodology