HX-20/21-1 ENDOSCOPIC LIGATOR— 510(k) K964661

Name: FDA 510(k) clearance K964661
Creator: U.S. Food and Drug Administration
Published: 1997-10-30

Substantially Equivalent

Olympus America, Inc.

FDA 510(k) clearance K964661 for HX-20/21-1 ENDOSCOPIC LIGATOR, Substantially Equivalent on 1997-10-30. Applicant: Olympus America, Inc.. Device class: 2.

Clearance details

Applicant: Olympus America, Inc.
Product code: Code MND
Device class: Class 2
Regulation: 21 CFR 876.4400
Advisory panel: Gastroenterology, Urology
Date received: 1996-11-20
Decision date: 1997-10-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Melville, NY, US

Download summary PDF View on FDA.gov ↗

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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.