Veineo System (00MEDRF4000TCUS 05CR45iT 06Pedal1St)
FDA 510(k) clearance K253918 · decided 2026-06-02
Clearance details
- K-number
- K253918
- Device name
- Veineo System (00MEDRF4000TCUS 05CR45iT 06Pedal1St)
- Applicant
- F Care Systems USA, LLC
- Decision
- Substantially Equivalent
- Date received
- 2025-12-08
- Decision date
- 2026-06-02
- Days to decision
- 176 days
- Clearance type
- Traditional
- Product code
- GEI
- Device class
- 2
- Regulation number
- 878.4400
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Miami, FL, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch F Care Systems USA
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
No recalls on record reference this clearance.