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

Name: FDA 510(k) clearance K223295
Creator: U.S. Food and Drug Administration
Published: 2023-01-11

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. Device class: 2.

Clearance details

Applicant: Fujifilm Corporaton
Product code: Code FDA
Device class: Class 2
Regulation: 21 CFR 876.1500
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 ↗

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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.