# K123463: Intuitive Surgical DA Vinci SI Surgical System Smartpedals

- Pathway: 510(k) (Special)
- Applicant: Intuitive Surgical, Inc.
- Decided: Dec 3, 2012 after 24 days
- Product code: NAY (System, Surgical, Computer Controlled Instrument)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 12 generations back to K930667 (1994). 53 ancestors in all.
148 later devices descend from it; 15 cite it directly.
1 of 202 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K081137: Intuitive Surgical DA Vinci SI Surgical System: Model IS3000, Intuitive Surgical, Inc. (2009)
- K090993: Intuitive Surgical Endoscopic Instrument Control Systems, Models IS1200, IS2000 and IS3000, Intuitive Surgical, Inc. (2009) Summary page 1.

## Most influential descendants
- K131861: DA Vinci Surgical System, Endowrist Instruments and Accessories (2014), 124 descendants of its own
- K141077: DA Vinci Firefly Imaging System (2014), 87 descendants of its own
- K150956: PINPOINT Endoscopic Fluorescence Imaging System (2016), 70 descendants of its own
- K161792: PINPOINT Endoscopic Fluorescence Imaging System (2016), 68 descendants of its own
- K182606: PINPOINT Endoscopic Fluorescence Imaging System (2018), 44 descendants of its own

## Recalls of this device
- Jan 15, 2015 · Class II · Z-1048-2015: The Wall chart has been updated because it was noted that Wall Chart (PN 551524-03 Rev A) was inconsistent with the User Manual Adendum (PN 550986-07_B) with regards to neceassary sterilization dry ti
- Sep 18, 2014 · Class II · Z-0074-2015: Intuitive is issuing an urgent product notice to all users of the EndoWrist Stapler 45 to discontinue use due to reports of inability to remove the stapler from tissue.

## Indications for use
The Intuitive Surgical Endoscopic Instrument Control System is intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments including rigid endoscopes, blunt and sharp endoscopic dissectors, scissors, scalpels, ultrasonic shears, forceps/pick-ups, needle holders, endoscopic retractors, stabilizers, 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, transoral otolaryngology surgical procedures restricted to benign and malignant tumors classified as TI and T2, 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 (except for transoral otolaryngology surgical procedures). 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/K123463
Methodology: https://510kreport.com/methodology