FDA 510(k)

STERiJECT Low Dead Space, STERiJECT The Invisible Needle

Número K: K231734 · 2024-03-08

RequerenteTsk Laboratory International Japan KK

Data da decisão2024-03-08

Código do produtoQNS

Comité consultivoHO

DecisãoSubstantially Equivalent

Resumo do dispositivo

STERiJECT Low Dead Space, STERiJECT The Invisible Needle is the device name listed in this FDA 510(k) record. The listed applicant is Tsk Laboratory International Japan KK. It received FDA 510(k) clearance on 2024-03-08 under 510(k) number K231734. The device is classified under product code QNS. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the STERiJECT Low Dead Space, STERiJECT The Invisible Needle?

STERiJECT Low Dead Space, STERiJECT The Invisible Needle is a medical device that received FDA 510(k) clearance on 2024-03-08. The listed applicant is Tsk Laboratory International Japan KK. The 510(k) number is K231734.

When did STERiJECT Low Dead Space, STERiJECT The Invisible Needle receive FDA 510(k) clearance?

STERiJECT Low Dead Space, STERiJECT The Invisible Needle received FDA 510(k) clearance on 2024-03-08, under 510(k) number K231734.

Who is the listed applicant for STERiJECT Low Dead Space, STERiJECT The Invisible Needle?

The FDA 510(k) record lists Tsk Laboratory International Japan KK as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for STERiJECT Low Dead Space, STERiJECT The Invisible Needle?

The FDA product code for STERiJECT Low Dead Space, STERiJECT The Invisible Needle is QNS.

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Outros registros que listam Tsk Laboratory International Japan KK como candidato(a)

K242073STERiJECT Ophthalmic Needle; STERiJECT Ophthalmic Needle Low Dead Space (LDS)

Dispositivos Relacionados (Código: QNS)

K242956LDS Needle; OcuSafe® LDS Needle; SteriCap® LDS Safety Needle; VitreJect® LDS Safety NeedleOcuject, LLC K210444EZ-Injec LDV Sterile Safety NeedlePoonglim Pharmatech, Inc.

Fonte oficial

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