DA VINCI FLUORESCENCE IMAGING VISION SYSTEM, MODEL FF 100— 510(k) K101077

Substantially Equivalent

Intuitive Surgical, Inc.

FDA 510(k) clearance K101077 for DA VINCI FLUORESCENCE IMAGING VISION SYSTEM, MODEL FF 100, Substantially Equivalent on 2011-02-04. Applicant: Intuitive Surgical, Inc..

Clearance details

Applicant: Intuitive Surgical, Inc.
Product code: Code GCJ
Advisory panel: Gastroenterology, Urology
Date received: 2010-04-19
Decision date: 2011-02-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sunnyvale, 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.