OLYMPUS HIGH FLOW INSUFFLATION UNIT— 510(k) K953162

Substantially Equivalent

Olympus America, Inc.

FDA 510(k) clearance K953162 for OLYMPUS HIGH FLOW INSUFFLATION UNIT, Substantially Equivalent on 1995-12-19. Applicant: Olympus America, Inc..

Clearance details

Applicant: Olympus America, Inc.
Product code: Code HIF
Advisory panel: Obstetrics/Gynecology
Date received: 1995-07-07
Decision date: 1995-12-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Melville, NY, US

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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.