FDA 510(k)
FDA class 2
Substantially Equivalent
🇳🇱 Netherlands
Fluido Compact System
K Number: K252636
·
Decision Nov 18, 2025
Classifications
1
FEI Numbers
71
Registration Numbers
71
Same Product Code
74
Applicant Total
3
Review Days
90
Basic Information
- Device Name
- Fluido Compact System
- K Number
- K252636
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5725
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- The Surgical Company International B.V.
- Date Received
- August 20, 2025
- Decision Date
- November 18, 2025
- Product Code
- LGZ
- Advisory Committee
- General Hospital
- Review Advisory Committee
- HO
- 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 |
|---|---|---|---|
| LGZ | Warmer, Thermal, Infusion Fluid | FDA class 2 | General Hospital |
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