da Vinci Fluorescence Imaging Vision System, da Vinci Firefly Imaging System— 510(k) K210918

Substantially Equivalent

Intuitive Surgical, Inc.

FDA 510(k) clearance K210918 for da Vinci Fluorescence Imaging Vision System, da Vinci Firefly Imaging System, Substantially Equivalent on 2021-04-26. Applicant: Intuitive Surgical, Inc..

Clearance details

Applicant: Intuitive Surgical, Inc.
Product code: Code NAY
Advisory panel: Gastroenterology, Urology
Date received: 2021-03-29
Decision date: 2021-04-26
Decision: Substantially Equivalent
Clearance type: Special
Location: Sunnyvale, CA, US

Download summary PDF View on FDA.gov ↗

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.