HS AMICA DEVICES FAMILY— 510(k) K150112

Substantially Equivalent

H.S Hospital Service S.P.A

FDA 510(k) clearance K150112 for HS AMICA DEVICES FAMILY, Substantially Equivalent on 2015-09-10. Applicant: H.S Hospital Service S.P.A.

Clearance details

Applicant: H.S Hospital Service S.P.A
Product code: Code GEI
Advisory panel: General, Plastic Surgery
Date received: 2015-01-20
Decision date: 2015-09-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Aprilia (Lt), IT

Download summary PDF View on FDA.gov ↗

Adverse events under product code GEI

product code GEI

Death: 133
Injury: 7,585
Malfunction: 35,808
Other: 44
Total: 43,570

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.