Veineo System (00MEDRF4000TCUS 05CR45iT 06Pedal1St)— 510(k) K253918
Substantially EquivalentF Care Systems USA, LLC
FDA 510(k) clearance K253918 for Veineo System (00MEDRF4000TCUS 05CR45iT 06Pedal1St), Substantially Equivalent on 2026-06-02. Applicant: F Care Systems USA, LLC.
Clearance details
- Applicant
- F Care Systems USA, LLC
- Product code
- Code GEI
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Miami, FL, US
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, through . 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.