VEGA— 510(k) K242859

Substantially Equivalent

Ibramed Equipamentos Médicos

FDA 510(k) clearance K242859 for VEGA, Substantially Equivalent on 2025-09-19. Applicant: Ibramed Equipamentos Médicos.

Clearance details

Applicant: Ibramed Equipamentos Médicos
Product code: Code GEX
Advisory panel: General, Plastic Surgery
Date received: 2024-09-20
Decision date: 2025-09-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Amparo, BR

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.