MYTHOS 500— 510(k) K030805

Substantially Equivalent

Msq (M2) , Ltd.

FDA 510(k) clearance K030805 for MYTHOS 500, Substantially Equivalent on 2003-05-21. Applicant: Msq (M2) , Ltd..

Clearance details

Applicant: Msq (M2) , Ltd.
Product code: Code GEX
Advisory panel: General, Plastic Surgery
Date received: 2003-03-13
Decision date: 2003-05-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ra'Ananna 43373, IL

Download summary PDF View on FDA.gov ↗

Adverse events under product code GEX

product code GEX

Death: 33
Injury: 3,045
Malfunction: 12,903
Other: 25
Total: 16,006

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.