ZenTite (Unicorn+); ZenTite (Unicorn+I); ZenTite (Unicorn+II); ZenTite (Unicorn+III)
K-Number: K254290 · 2026-01-30
Device Summary
Frequently Asked Questions
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.
Related Devices (Code: GEI)
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.
Official Source
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