K964661

Substantially Equivalent

HX-20/21-1 ENDOSCOPIC LIGATOR

Applicant: Olympus America, Inc.
Product code: MND
Advisory panel: Gastroenterology, Urology
Date received: 1996-11-20
Decision date: 1997-10-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Melville, NY, US

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.