da Vinci Xi Surgical System— 510(k) K152892

Substantially Equivalent

Intuitive Surgical

FDA 510(k) clearance K152892 for da Vinci Xi Surgical System, Substantially Equivalent on 2016-04-29. Applicant: Intuitive Surgical.

Clearance details

Applicant: Intuitive Surgical
Product code: Code NAY
Advisory panel: Gastroenterology, Urology
Date received: 2015-09-30
Decision date: 2016-04-29
Decision: Substantially Equivalent
Clearance type: Traditional
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.