da Vinci Surgical System, Model IS5000— 510(k) K261824

Name: FDA 510(k) clearance K261824
Creator: U.S. Food and Drug Administration
Published: 2026-07-31

Substantially Equivalent

Intuitive Surgical, Inc.

FDA 510(k) clearance K261824 for da Vinci Surgical System, Model IS5000, Substantially Equivalent on 2026-07-31. 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: 2026-06-01
Decision date: 2026-07-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sunnyvale, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code NAY

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K260695 — da Vinci Firefly Imaging System2026-05-22
K254192 — Senhance Ultrasonic System2026-05-12
K253986 — da Vinci Force Feedback Instruments2026-03-11
K251739 — da Vinci Surgical System (IS5000)2026-01-16
K253556 — da Vinci SP Surgical System (SP1098); da Vinci E-200 Generator2026-01-16

More clearances from Intuitive Surgical, Inc.

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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
K251763 — IRISeg2025-12-16
K252675 — da Vinci SP Surgical System (SP1098)2025-12-15

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.