FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Veineo System (00MEDRF4000TCUS 05CR45iT 06Pedal1St)
K Number: K253918
·
Decision Jun 2, 2026
Classifications
1
FEI Numbers
823
Registration Numbers
823
Same Product Code
2306
Applicant Total
4
Review Days
176
Basic Information
- Device Name
- Veineo System (00MEDRF4000TCUS 05CR45iT 06Pedal1St)
- K Number
- K253918
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4400
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- F Care Systems USA, LLC
- Date Received
- December 8, 2025
- Decision Date
- June 2, 2026
- Product Code
- GEI
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | FDA class 2 | General, Plastic Surgery |
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