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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 a medical device manufactured by The Surgical Company International BV (As Tsc Life). It received FDA 510(k) clearance on 2025-09-04 under approval 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. It is manufactured by The Surgical Company International BV (As Tsc Life). The 510(k) number is K251733.

When was Fluido® AirGuard System approved by the FDA?

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

What company makes Fluido® AirGuard System?

Fluido® AirGuard System is manufactured by The Surgical Company International BV (As Tsc Life).

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

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

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Official Source

View on FDA Database →

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