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FDA 510(k)

Fluido Compact System

K-Number: K252636 · 2025-11-18

ApplicantThe Surgical Company International B.V.
Decision Date2025-11-18
Product CodeLGZ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Fluido Compact System is a medical device manufactured by The Surgical Company International B.V.. It received FDA 510(k) clearance on 2025-11-18 under approval number K252636. The device is classified under product code LGZ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Fluido Compact System?

Fluido Compact System is a medical device that received FDA 510(k) clearance on 2025-11-18. It is manufactured by The Surgical Company International B.V.. The 510(k) number is K252636.

When was Fluido Compact System approved by the FDA?

Fluido Compact System received FDA 510(k) clearance on 2025-11-18, under approval number K252636.

What company makes Fluido Compact System?

Fluido Compact System is manufactured by The Surgical Company International B.V..

What is the FDA product code for Fluido Compact System?

The FDA product code for Fluido Compact System is LGZ.

Related Clinical Trials

NCT07233876 DuoCor 2 DOMINATE Study NOT_YET_RECRUITING NCT07281222 Evaluation of the FYNA Research OPM MEG Device for Locating Epileptic Foci as Part of Pre-surgical Assessment of Epilepsy NOT_YET_RECRUITING

Other Devices by The Surgical Company International B.V.

K211618Fluido Compact Blood and Fluid Warming System

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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