MODIFICATION TO INTUITIVE SURGICAL STEREO VIEW ENDOSCOPIC SYSTEM— 510(k) K001666

Substantially Equivalent

Intuitive Surgical, Inc.

FDA 510(k) clearance K001666 for MODIFICATION TO INTUITIVE SURGICAL STEREO VIEW ENDOSCOPIC SYSTEM, Substantially Equivalent on 2000-08-24. Applicant: Intuitive Surgical, Inc..

Clearance details

Applicant: Intuitive Surgical, Inc.
Product code: Code GCJ
Advisory panel: Gastroenterology, Urology
Date received: 2000-05-31
Decision date: 2000-08-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mountain View, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code GCJ

product code GCJ

Death: 39
Injury: 1,638
Malfunction: 28,216
Other: 11
Total: 29,904

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.