FDA 510(k)

Zenflow Spring Scope

Numéro K : K251140 · 2025-09-23

Date de décision2025-09-23

Code produitFAJ

Comité consultatifGU

DécisionSubstantially Equivalent

Résumé du dispositif

Zenflow Spring Scope is the device name listed in this FDA 510(k) record. The listed applicant is Zenflow, Inc.. It received FDA 510(k) clearance on 2025-09-23 under 510(k) number K251140. The device is classified under product code FAJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the Zenflow Spring Scope?

Zenflow Spring Scope is a medical device that received FDA 510(k) clearance on 2025-09-23. The listed applicant is Zenflow, Inc.. The 510(k) number is K251140.

When did Zenflow Spring Scope receive FDA 510(k) clearance?

Zenflow Spring Scope received FDA 510(k) clearance on 2025-09-23, under 510(k) number K251140.

Who is the listed applicant for Zenflow Spring Scope?

The FDA 510(k) record lists Zenflow, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Zenflow Spring Scope?

The FDA product code for Zenflow Spring Scope is FAJ.

Essais cliniques associés

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Dispositifs connexes (Code : FAJ)

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Source officielle

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