FDA 510(k)

Fluido® AirGuard System

Numéro K : K251733 · 2025-09-04

DemandeurThe Surgical Company International BV (As Tsc Life)

Date de décision2025-09-04

Code produitLGZ

Comité consultatifHO

DécisionSubstantially Equivalent

Résumé du dispositif

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.

Questions fréquentes

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.

Essais cliniques associés

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Source officielle

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