Frax 1550 for Ellipse Nordlys/ Ellipse Nordlys+, Ellipse Sirius, Ellipse Infinity, Ellipse Mjolner, Ellipse Nordlys Ultra— 510(k) K161162

Substantially Equivalent

Ellipse A/S

FDA 510(k) clearance K161162 for Frax 1550 for Ellipse Nordlys/ Ellipse Nordlys+, Ellipse Sirius, Ellipse Infinity, Ellipse Mjolner, Ellipse Nordlys Ultra, Substantially Equivalent on 2016-09-16. Applicant: Ellipse A/S.

Clearance details

Applicant: Ellipse A/S
Product code: Code GEX
Advisory panel: General, Plastic Surgery
Date received: 2016-04-25
Decision date: 2016-09-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hoersholm, DK

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.