MODIFICATION TO INTUITIVE SURGICAL DA VINCI SURGICAL SYSTEM AND ENDOSCOPIC INSTRUMENTS— 510(k) K043288

Name: FDA 510(k) clearance K043288
Creator: U.S. Food and Drug Administration
Published: 2005-03-03

Substantially Equivalent

Intuitive Surgical, Inc.

FDA 510(k) clearance K043288 for MODIFICATION TO INTUITIVE SURGICAL DA VINCI SURGICAL SYSTEM AND ENDOSCOPIC INSTRUMENTS, Substantially Equivalent on 2005-03-03. Applicant: Intuitive Surgical, Inc.. Device class: 2.

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: 2004-11-29
Decision date: 2005-03-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sunnyvale, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code NAY

view all

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

More clearances from Intuitive Surgical, Inc.

view all

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

Adverse events under product code NAY

product code NAY

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 →

Data sourced from openFDA. This site is unofficial and independent of the FDA.