FDA 510(k)

Pen Injector Needle 32.5

Número K: K250700 · 2025-11-21

Data da decisão2025-11-21

Código do produtoFMI

Comité consultivoHO

DecisãoSubstantially Equivalent

Resumo do dispositivo

Pen Injector Needle 32.5 is the device name listed in this FDA 510(k) record. The listed applicant is Terumo Corporation. It received FDA 510(k) clearance on 2025-11-21 under 510(k) number K250700. The device is classified under product code FMI. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Pen Injector Needle 32.5?

Pen Injector Needle 32.5 is a medical device that received FDA 510(k) clearance on 2025-11-21. The listed applicant is Terumo Corporation. The 510(k) number is K250700.

When did Pen Injector Needle 32.5 receive FDA 510(k) clearance?

Pen Injector Needle 32.5 received FDA 510(k) clearance on 2025-11-21, under 510(k) number K250700.

Who is the listed applicant for Pen Injector Needle 32.5?

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

What is the FDA product code for Pen Injector Needle 32.5?

The FDA product code for Pen Injector Needle 32.5 is FMI.

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Fonte oficial

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