FDA 510(k)

TruPress

Número K: K254074 · 2026-09-10

Data da decisão2026-09-10

Código do produtoDRS

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

TruPress is the device name listed in this FDA 510(k) record. The listed applicant is Procerus Enterprises. It received FDA 510(k) clearance on 2026-09-10 under 510(k) number K254074. The device is classified under product code DRS. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the TruPress?

TruPress is a medical device that received FDA 510(k) clearance on 2026-09-10. The listed applicant is Procerus Enterprises. The 510(k) number is K254074.

When did TruPress receive FDA 510(k) clearance?

TruPress received FDA 510(k) clearance on 2026-09-10, under 510(k) number K254074.

Who is the listed applicant for TruPress?

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

What is the FDA product code for TruPress?

The FDA product code for TruPress is DRS.

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Fonte oficial

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