Endoscope Model EN-580T, Over-tube TS-1314B, Balloon BS-4, Tube Kit TY-500D— 510(k) K223295

Substantially Equivalent

Fujifilm Corporaton

FDA 510(k) clearance K223295 for Endoscope Model EN-580T, Over-tube TS-1314B, Balloon BS-4, Tube Kit TY-500D, Substantially Equivalent on 2023-01-11. Applicant: Fujifilm Corporaton.

Clearance details

Applicant: Fujifilm Corporaton
Product code: Code FDA
Advisory panel: Gastroenterology, Urology
Date received: 2022-10-26
Decision date: 2023-01-11
Decision: Substantially Equivalent
Clearance type: Special
Location: Ashigara Kami-Gun, JP

Download summary PDF View on FDA.gov ↗

Adverse events under product code FDA

product code FDA

Death: 8
Injury: 148
Total: 156

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.