OLYMPUS HX-20 SERIES LIGATING DEVICE— 510(k) K984255

Substantially Equivalent

Olympus Corp of America

FDA 510(k) clearance K984255 for OLYMPUS HX-20 SERIES LIGATING DEVICE, Substantially Equivalent on 1999-01-12. Applicant: Olympus Corp of America.

Clearance details

Applicant: Olympus Corp of America
Product code: Code MND
Advisory panel: Gastroenterology, Urology
Date received: 1998-11-30
Decision date: 1999-01-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lake Success, NY, US

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Adverse events under product code MND

product code MND

Death: 6
Injury: 255
Malfunction: 4,495
Total: 4,756

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.