SMARTXIDE 50 HS/MS— 510(k) K101904

Substantially Equivalent

El.En Electronic Engineering Spa

FDA 510(k) clearance K101904 for SMARTXIDE 50 HS/MS, Substantially Equivalent on 2011-01-12. Applicant: El.En Electronic Engineering Spa.

Clearance details

Applicant: El.En Electronic Engineering Spa
Product code: Code GEX
Advisory panel: General, Plastic Surgery
Date received: 2010-07-08
Decision date: 2011-01-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Calenzano, IT

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.