FDA 510(k)

Disposable Blood Lancet (Soft Pro); Disposable Blood Lancet (Softsure); Disposable Blood Lancet (Softsure Pro); Disposable Blood Lancet (Softsense)

Número K: K244031 · 2025-02-26

RequerenteSteriLance Medical (Suzhou), Inc.

Data da decisão2025-02-26

Código do produtoQRK

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Disposable Blood Lancet (Soft Pro); Disposable Blood Lancet (Softsure); Disposable Blood Lancet (Softsure Pro); Disposable Blood Lancet (Softsense) is the device name listed in this FDA 510(k) record. The listed applicant is SteriLance Medical (Suzhou), Inc.. It received FDA 510(k) clearance on 2025-02-26 under 510(k) number K244031. The device is classified under product code QRK. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Disposable Blood Lancet (Soft Pro); Disposable Blood Lancet (Softsure); Disposable Blood Lancet (Softsure Pro); Disposable Blood Lancet (Softsense)?

Disposable Blood Lancet (Soft Pro); Disposable Blood Lancet (Softsure); Disposable Blood Lancet (Softsure Pro); Disposable Blood Lancet (Softsense) is a medical device that received FDA 510(k) clearance on 2025-02-26. The listed applicant is SteriLance Medical (Suzhou), Inc.. The 510(k) number is K244031.

When did Disposable Blood Lancet (Soft Pro); Disposable Blood Lancet (Softsure); Disposable Blood Lancet (Softsure Pro); Disposable Blood Lancet (Softsense) receive FDA 510(k) clearance?

Disposable Blood Lancet (Soft Pro); Disposable Blood Lancet (Softsure); Disposable Blood Lancet (Softsure Pro); Disposable Blood Lancet (Softsense) received FDA 510(k) clearance on 2025-02-26, under 510(k) number K244031.

Who is the listed applicant for Disposable Blood Lancet (Soft Pro); Disposable Blood Lancet (Softsure); Disposable Blood Lancet (Softsure Pro); Disposable Blood Lancet (Softsense)?

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

What is the FDA product code for Disposable Blood Lancet (Soft Pro); Disposable Blood Lancet (Softsure); Disposable Blood Lancet (Softsure Pro); Disposable Blood Lancet (Softsense)?

The FDA product code for Disposable Blood Lancet (Soft Pro); Disposable Blood Lancet (Softsure); Disposable Blood Lancet (Softsure Pro); Disposable Blood Lancet (Softsense) is QRK.

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Outros registros que listam SteriLance Medical (Suzhou), Inc. como candidato(a)

K262631Disposable blood lancet (Soft Pro, Softsure, Softsure Pro, Softsense)K260122Lancing Device (PressGo, LDE3, LDE3AST, LDE5, EasyStep)K261634Disposable Blood Lancet (Soft)K244036Heel Incision Safety Lancet (SteriHeel 2)K233796Disposable safety lancet (Impress); Disposable safety lancet (Impress Pro); Disposable safety lancet (Lite4); Disposable blood lancet (Elite); Disposable blood lancet (Elite Pro)K221521Disposable Safety Lancet

Ver todos os 11 dispositivos →

Dispositivos Relacionados (Código: QRK)

K262631Disposable blood lancet (Soft Pro, Softsure, Softsure Pro, Softsense)SteriLance Medical (Suzhou), Inc.K261634Disposable Blood Lancet (Soft)SteriLance Medical (Suzhou), Inc.K250016droplet® personal lancetsHtl-Strefa S.A K242622Sterile Lancets for Single UseNingbo Caremed Medical Products Co., Ltd.K241810MICROLET®NEXT LancetAscensia Diabetes Care U.S., Inc.K232330Lancing SystemNingbo Medsun Medical Co., Ltd.

Fonte oficial

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