FDA 510(k)

Sterile Auto-Disable Syringes with/without Needle for Single Use

Número K: K211210 · 2022-01-27

Data da decisão2022-01-27

Código do produtoFMF

Comité consultivoHO

DecisãoSubstantially Equivalent

Resumo do dispositivo

Sterile Auto-Disable Syringes with/without Needle for Single Use is the device name listed in this FDA 510(k) record. The listed applicant is Azur Medical Company, Inc.. It received FDA 510(k) clearance on 2022-01-27 under 510(k) number K211210. The device is classified under product code FMF. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Sterile Auto-Disable Syringes with/without Needle for Single Use?

Sterile Auto-Disable Syringes with/without Needle for Single Use is a medical device that received FDA 510(k) clearance on 2022-01-27. The listed applicant is Azur Medical Company, Inc.. The 510(k) number is K211210.

When did Sterile Auto-Disable Syringes with/without Needle for Single Use receive FDA 510(k) clearance?

Sterile Auto-Disable Syringes with/without Needle for Single Use received FDA 510(k) clearance on 2022-01-27, under 510(k) number K211210.

Who is the listed applicant for Sterile Auto-Disable Syringes with/without Needle for Single Use?

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

What is the FDA product code for Sterile Auto-Disable Syringes with/without Needle for Single Use?

The FDA product code for Sterile Auto-Disable Syringes with/without Needle for Single Use is FMF.

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Outros registros que listam Azur Medical Company, Inc. como candidato(a)

K231719Medical Surgical Mask K211214Sterile Hypodermic Needles for Single Use K211211Sterile syringes for single use with/without needle

Dispositivos Relacionados (Código: FMF)

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Fonte oficial

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