510(k) K252636
K252636 is an FDA 510(k) premarket notification submitted by The Surgical Company International B.V. for the device "Fluido Compact System". The FDA issued a decision of Substantially Equivalent on November 18, 2025. The device falls under product code LGZ (Warmer, Thermal, Infusion Fluid), a Class II device regulated under 21 CFR 880.5725. The Surgical Company International B.V. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 18, 2025
- Date Received
- August 20, 2025
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Warmer, Thermal, Infusion Fluid
- Device Class
- Class II
- Regulation Number
- 880.5725
- Review Panel
- HO
- Submission Type