Disposable Balloon Catheter B5-2C— 510(k) K250118

Substantially Equivalent

Olympus Medical Systems Corporation

FDA 510(k) clearance K250118 for Disposable Balloon Catheter B5-2C, Substantially Equivalent on 2025-06-04. Applicant: Olympus Medical Systems Corporation.

Clearance details

Applicant: Olympus Medical Systems Corporation
Product code: Code EOQ
Advisory panel: Ear, Nose, Throat
Date received: 2025-01-16
Decision date: 2025-06-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hachioji-Shi, JP

Download summary PDF View on FDA.gov ↗

Adverse events under product code EOQ

product code EOQ

Death: 135
Injury: 2,863
Malfunction: 21,662
Total: 24,660

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.