Disposable Balloon Catheter (3 models)— 510(k) K250409

Name: FDA 510(k) clearance K250409
Creator: U.S. Food and Drug Administration
Published: 2025-10-21

Substantially Equivalent

Olympus Medical Systems Corporation

FDA 510(k) clearance K250409 for Disposable Balloon Catheter (3 models), Substantially Equivalent on 2025-10-21. Applicant: Olympus Medical Systems Corporation. Device class: 2.

Clearance details

Device name as filed: Disposable Balloon Catheter (B5-2Q); Disposable Balloon Catheter (B7-2Q); Disposable Balloon Catheter (B7-2LA)
Applicant: Olympus Medical Systems Corporation
Product code: Code FGE
Device class: Class 2
Regulation: 21 CFR 876.5010
Advisory panel: Gastroenterology, Urology
Date received: 2025-02-13
Decision date: 2025-10-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hachioji-Shi, JP

Download summary PDF View on FDA.gov ↗

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Adverse events under product code FGE

product code FGE

Death: 52
Injury: 2,347
Malfunction: 9,798
Other: 1
Total: 12,198

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.