FUJIFILM Video Laparoscope— 510(k) K202130

Substantially Equivalent

Fujifilm Corporation

FDA 510(k) clearance K202130 for FUJIFILM Video Laparoscope, Substantially Equivalent on 2020-08-20. Applicant: Fujifilm Corporation.

Clearance details

Applicant: Fujifilm Corporation
Product code: Code GCJ
Advisory panel: Gastroenterology, Urology
Date received: 2020-07-31
Decision date: 2020-08-20
Decision: Substantially Equivalent
Clearance type: Special
Location: Ashigara Kami-Gun, JP

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.