FDA 510(k)

IO Needle Safety Sheath

Número K: K220890 · 2022-10-31

Data da decisão2022-10-31

Código do produtoFMI

Comité consultivoHO

DecisãoSubstantially Equivalent

Resumo do dispositivo

IO Needle Safety Sheath is the device name listed in this FDA 510(k) record. The listed applicant is Actuated Medical, Inc.. It received FDA 510(k) clearance on 2022-10-31 under 510(k) number K220890. 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 IO Needle Safety Sheath?

IO Needle Safety Sheath is a medical device that received FDA 510(k) clearance on 2022-10-31. The listed applicant is Actuated Medical, Inc.. The 510(k) number is K220890.

When did IO Needle Safety Sheath receive FDA 510(k) clearance?

IO Needle Safety Sheath received FDA 510(k) clearance on 2022-10-31, under 510(k) number K220890.

Who is the listed applicant for IO Needle Safety Sheath?

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

What is the FDA product code for IO Needle Safety Sheath?

The FDA product code for IO Needle Safety Sheath is FMI.

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