FDA 510(k)

Lancing device

N.º K: K221970 · 2022-08-30

SolicitanteSteriLance Medical (Suzhou), Inc.

Fecha de decisión2022-08-30

Código de productoQRL

Comité asesorSU

DecisiónSubstantially Equivalent

Resumen del dispositivo

Lancing device 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 2022-08-30 under 510(k) number K221970. The device is classified under product code QRL. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Lancing device?

Lancing device is a medical device that received FDA 510(k) clearance on 2022-08-30. The listed applicant is SteriLance Medical (Suzhou), Inc.. The 510(k) number is K221970.

When did Lancing device receive FDA 510(k) clearance?

Lancing device received FDA 510(k) clearance on 2022-08-30, under 510(k) number K221970.

Who is the listed applicant for Lancing device?

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 Lancing device?

The FDA product code for Lancing device is QRL.

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Otros registros que enlistan a SteriLance Medical (Suzhou), Inc. como solicitante

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)K244031Disposable Blood Lancet (Soft Pro); Disposable Blood Lancet (Softsure); Disposable Blood Lancet (Softsure Pro); Disposable Blood Lancet (Softsense)K233796Disposable safety lancet (Impress); Disposable safety lancet (Impress Pro); Disposable safety lancet (Lite4); Disposable blood lancet (Elite); Disposable blood lancet (Elite Pro)

Ver todos los 11 dispositivos →

Dispositivos relacionados (Código: QRL)

K262135Lancing deviceTianjin Huahong Technology Co., Ltd.K262211LancetTianjin Huahong Technology Co., Ltd.K260122Lancing Device (PressGo, LDE3, LDE3AST, LDE5, EasyStep)SteriLance Medical (Suzhou), Inc.K253706Lancing device (HH-XV-T)Tianjin Huahong Technology Co., Ltd.K250813MICROLET®NEXT 2 Lancing DeviceAscensia Diabetes Care U.S., Inc.K243306Lancet (IA, IB, IC, ID, IE, IK, IL, IM, IIA, IIB, III, V, VI, VII, VIII, IX); Lancing device (HH-X-T, HH-XV-T, HH-XVI-T, HH-XVII-T, HH-XVIII-T, HH-XIX, HH-XXI-T, HH-XXII-T, HH-XXIII-T, HH-XXIV-T, HH-XXV-T, HH-XXVI-T, HH-XXVIII-T, HH-XXIX-T, HH-XXX-T, HH-XIII-T, HH-XXVII-T)Tianjin Huahong Technology Co., Ltd.

Fuente oficial

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