K093217

Substantially Equivalent

5 MM HARMONIC ACE INSTRUMENT (USED WITH DA VINCI IS1200 & IS2000/IS3000 SYSTEM)

Applicant: Intuitive Surgical, Inc.
Product code: NAY
Advisory panel: Gastroenterology, Urology
Date received: 2009-10-13
Decision date: 2010-01-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sunnyvale, CA, US

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.