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FDA 510(k)

Fluido® AirGuard System

K-Number: K251733 · 2025-09-04

ApplicantThe Surgical Company International BV (As Tsc Life)
Decision Date2025-09-04
Product CodeLGZ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Fluido® AirGuard System is the device name listed in this FDA 510(k) record. The listed applicant is The Surgical Company International BV (As Tsc Life). It received FDA 510(k) clearance on 2025-09-04 under 510(k) number K251733. 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® AirGuard System?

Fluido® AirGuard System is a medical device that received FDA 510(k) clearance on 2025-09-04. The listed applicant is The Surgical Company International BV (As Tsc Life). The 510(k) number is K251733.

When did Fluido® AirGuard System receive FDA 510(k) clearance?

Fluido® AirGuard System received FDA 510(k) clearance on 2025-09-04, under 510(k) number K251733.

Who is the listed applicant for Fluido® AirGuard System?

The FDA 510(k) record lists The Surgical Company International BV (As Tsc Life) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Fluido® AirGuard System?

The FDA product code for Fluido® AirGuard System is LGZ.

Related Devices (Code: LGZ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260988°M Warmer System with °M StationMequ A/SK252636Fluido Compact SystemThe Surgical Company International B.V.K232107°M Warmer SystemMequ A/SK211618Fluido Compact Blood and Fluid Warming SystemThe Surgical Company International B.V.K211800Warrior Blood and Fluid Warmer, Warrior EXTREME Blood and Fluid Warmer, Warrior Lite Blood and Fluid WarmerQuality IN Flow , Ltd.K202461ThermaCor 1200 Disposable Sets for the ThermaCor 1200 Rapid Thermal Infusion SystemSmisson-Cartledge Biomedical, LLC

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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