FDA 510(k)

ZenTite (Unicorn+); ZenTite (Unicorn+I); ZenTite (Unicorn+II); ZenTite (Unicorn+III)

Numéro K : K254290 · 2026-01-30

DemandeurShenzhen Peninsula Medical Group

Date de décision2026-01-30

Code produitGEI

Comité consultatifSU

DécisionSubstantially Equivalent

Résumé du dispositif

ZenTite (Unicorn+); ZenTite (Unicorn+I); ZenTite (Unicorn+II); ZenTite (Unicorn+III) is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Peninsula Medical Group. It received FDA 510(k) clearance on 2026-01-30 under 510(k) number K254290. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the ZenTite (Unicorn+); ZenTite (Unicorn+I); ZenTite (Unicorn+II); ZenTite (Unicorn+III)?

ZenTite (Unicorn+); ZenTite (Unicorn+I); ZenTite (Unicorn+II); ZenTite (Unicorn+III) is a medical device that received FDA 510(k) clearance on 2026-01-30. The listed applicant is Shenzhen Peninsula Medical Group. The 510(k) number is K254290.

When did ZenTite (Unicorn+); ZenTite (Unicorn+I); ZenTite (Unicorn+II); ZenTite (Unicorn+III) receive FDA 510(k) clearance?

ZenTite (Unicorn+); ZenTite (Unicorn+I); ZenTite (Unicorn+II); ZenTite (Unicorn+III) received FDA 510(k) clearance on 2026-01-30, under 510(k) number K254290.

Who is the listed applicant for ZenTite (Unicorn+); ZenTite (Unicorn+I); ZenTite (Unicorn+II); ZenTite (Unicorn+III)?

The FDA 510(k) record lists Shenzhen Peninsula Medical Group as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ZenTite (Unicorn+); ZenTite (Unicorn+I); ZenTite (Unicorn+II); ZenTite (Unicorn+III)?

The FDA product code for ZenTite (Unicorn+); ZenTite (Unicorn+I); ZenTite (Unicorn+II); ZenTite (Unicorn+III) is GEI.

Essais cliniques associés

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Dispositifs connexes (Code : GEI)

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Source officielle

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