OLYMPUS ENDOSCOPIC LIGATION DEVICE— 510(k) K001744

Substantially Equivalent

Olympus America, Inc.

FDA 510(k) clearance K001744 for OLYMPUS ENDOSCOPIC LIGATION DEVICE, Substantially Equivalent on 2001-02-27. Applicant: Olympus America, Inc..

Clearance details

Applicant: Olympus America, Inc.
Product code: Code MND
Advisory panel: Gastroenterology, Urology
Date received: 2000-06-08
Decision date: 2001-02-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Melville, NY, US

Download summary PDF View on FDA.gov ↗

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.