FDA 510(k)

LiNA OperaScope Needle

Número K: K221085 · 2022-09-02

Data da decisão2022-09-02

Código do produtoFBK

Comité consultivoGU

DecisãoSubstantially Equivalent

Resumo do dispositivo

LiNA OperaScope Needle is the device name listed in this FDA 510(k) record. The listed applicant is Lina Medical Aps. It received FDA 510(k) clearance on 2022-09-02 under 510(k) number K221085. The device is classified under product code FBK. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the LiNA OperaScope Needle?

LiNA OperaScope Needle is a medical device that received FDA 510(k) clearance on 2022-09-02. The listed applicant is Lina Medical Aps. The 510(k) number is K221085.

When did LiNA OperaScope Needle receive FDA 510(k) clearance?

LiNA OperaScope Needle received FDA 510(k) clearance on 2022-09-02, under 510(k) number K221085.

Who is the listed applicant for LiNA OperaScope Needle?

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

What is the FDA product code for LiNA OperaScope Needle?

The FDA product code for LiNA OperaScope Needle is FBK.

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Outros registros que listam Lina Medical Aps como candidato(a)

K240227LiNA CystoVu™ HD (CYV-100-5; CYV-101-5); LiNA ScopeVu™ (SCP-100-1)K223932SafeAir combi (SFR-combi-US)K193007LiNA OperaScope with HDMI cable and on-board LCD - 6 units, LiNA OperaScope Recording Module K182224SafeAir Smoke Evacuator compact K182354SafeAir Telescopic Smoke Pencil K171113LiNA OperaScope with HDMI cable and on-board LCD-single unit, LiNA OperaScope with HDMI cable and on-board LCD-6 units, LiNA OperaScope Recording Module

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Fonte oficial

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