INTUITIVE SURGICAL DA VINCI SI SURGICAL SYSTEM SMARTPEDALS— 510(k) K123463

Clearance details

Applicant

Intuitive Surgical, Inc.

Product code

Code NAY

Device class

Class 2

Regulation

21 CFR 876.1500

Advisory panel

Gastroenterology, Urology

Date received

2012-11-09

Decision date

2012-12-03

Decision

Substantially Equivalent

Clearance type

Special

Location

Sunnyvale, CA, US

• K261823 — da Vinci Surgical System, Model IS50002026-09-08
• K261824 — da Vinci Surgical System, Model IS50002026-07-31
• K260695 — da Vinci Firefly Imaging System2026-05-22
• K254192 — Senhance Ultrasonic System2026-05-12
• K253986 — da Vinci Force Feedback Instruments2026-03-11

• K253702 — Intuitive Endoluminal Gastrointestinal System (IG1000)2026-08-07
• K261249 — Universal Seal (5-12 mm)2026-07-14
• K253978 — Universal Seal (5-12 mm)2026-02-24
• K251739 — da Vinci Surgical System (IS5000)2026-01-16
• K253556 — da Vinci SP Surgical System (SP1098); da Vinci E-200 Generator2026-01-16

Death

433

Injury

7,927

Malfunction

93,790

Other

19

Total

102,169

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

• Z-1048-2015 — da Vinci Si Surgical System, IS3000; - Wall chart for EndoWrist Stapler 45 System. Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.Class II·Terminated·Intuitive Surgical, Inc.·20150115
• Z-0074-2015 — EndoWrist Stapler 45 instrument for the da Vinci Si System Model Number: IS3000 Product Usage: For use with da Vinci Si System. 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.Class II·Terminated·Intuitive Surgical, Inc.·20140918

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K123463.