Ellipse Frax 1940 for Ellipse Nordlys and Ellipse Ydun— 510(k) K192951

Substantially Equivalent

Ellipse A/S

FDA 510(k) clearance K192951 for Ellipse Frax 1940 for Ellipse Nordlys and Ellipse Ydun, Substantially Equivalent on 2020-03-26. Applicant: Ellipse A/S.

Clearance details

Applicant: Ellipse A/S
Product code: Code GEX
Advisory panel: General, Plastic Surgery
Date received: 2019-10-21
Decision date: 2020-03-26
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.