da Vinci X/Xi 8mm Endoscope Plus, 0, da Vinci X/Xi 8mm Endoscope Plus, 30— 510(k) K191736

Substantially Equivalent

Intuitive Surgical

FDA 510(k) clearance K191736 for da Vinci X/Xi 8mm Endoscope Plus, 0, da Vinci X/Xi 8mm Endoscope Plus, 30, Substantially Equivalent on 2019-07-26. Applicant: Intuitive Surgical.

Clearance details

Applicant: Intuitive Surgical
Product code: Code NAY
Advisory panel: Gastroenterology, Urology
Date received: 2019-06-28
Decision date: 2019-07-26
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.