AUTO-BAND LIGATOR— 510(k) K081142

Substantially Equivalent

Scandimed International

FDA 510(k) clearance K081142 for AUTO-BAND LIGATOR, Substantially Equivalent on 2008-05-16. Applicant: Scandimed International.

Clearance details

Applicant: Scandimed International
Product code: Code MND
Advisory panel: Gastroenterology, Urology
Date received: 2008-04-22
Decision date: 2008-05-16
Decision: Substantially Equivalent
Clearance type: Special
Location: Glostrop, DK

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.