510(k) K261880— FUJIFILM Processor EP-8000;Balloon Controller PB-30;Endoscopy Support Program EW10-VM01

Substantially Equivalent

Fujifilm Corporation

Clearance details

Applicant: Fujifilm Corporation
Product code: Code FET
Advisory panel: Gastroenterology, Urology
Date received: 2026-06-05
Decision date: 2026-07-02
Decision: Substantially Equivalent
Clearance type: Special
Location: Ashigarakami-Gun, JP

Adverse events under product code FET

product code FET

Injury: 313
Malfunction: 54,276
Total: 54,589

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.