FAS ENDOLUMINAL BRUSH— 510(k) K012641

Substantially Equivalent

Fas Medical , Ltd.

FDA 510(k) clearance K012641 for FAS ENDOLUMINAL BRUSH, Substantially Equivalent on 2001-10-15. Applicant: Fas Medical , Ltd..

Clearance details

Applicant: Fas Medical , Ltd.
Product code: Code LJS
Advisory panel: General Hospital
Date received: 2001-08-13
Decision date: 2001-10-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Indian Hills, CO, US

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Adverse events under product code LJS

product code LJS

Death: 31
Injury: 2,791
Malfunction: 18,374
Other: 5
Total: 21,201

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.