High Flow Insufflation Unit (UHI-4)— 510(k) K243527

Substantially Equivalent

Olympus Medical Systems Corporation

FDA 510(k) clearance K243527 for High Flow Insufflation Unit (UHI-4), Substantially Equivalent on 2025-01-13. Applicant: Olympus Medical Systems Corporation.

Clearance details

Applicant: Olympus Medical Systems Corporation
Product code: Code HIF
Advisory panel: Obstetrics/Gynecology
Date received: 2024-11-14
Decision date: 2025-01-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hachioji-Shi, JP

Download summary PDF View on FDA.gov ↗

Adverse events under product code HIF

product code HIF

Death: 19
Injury: 578
Malfunction: 5,639
Total: 6,236

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.