FDA 510(k)

Automatic Core Biopsy Instrument/ Semi-Automatic Core Biopsy Instrument/ Disposable Coaxial Biopsy Needle

N.º K: K241793 · 2025-01-24

SolicitanteZhejiang Curaway Medical Technology Co., Ltd.

Fecha de decisión2025-01-24

Código de productoKNW

Comité asesorGU

DecisiónSubstantially Equivalent

Resumen del dispositivo

Automatic Core Biopsy Instrument/ Semi-Automatic Core Biopsy Instrument/ Disposable Coaxial Biopsy Needle is the device name listed in this FDA 510(k) record. The listed applicant is Zhejiang Curaway Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2025-01-24 under 510(k) number K241793. The device is classified under product code KNW. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Automatic Core Biopsy Instrument/ Semi-Automatic Core Biopsy Instrument/ Disposable Coaxial Biopsy Needle?

Automatic Core Biopsy Instrument/ Semi-Automatic Core Biopsy Instrument/ Disposable Coaxial Biopsy Needle is a medical device that received FDA 510(k) clearance on 2025-01-24. The listed applicant is Zhejiang Curaway Medical Technology Co., Ltd.. The 510(k) number is K241793.

When did Automatic Core Biopsy Instrument/ Semi-Automatic Core Biopsy Instrument/ Disposable Coaxial Biopsy Needle receive FDA 510(k) clearance?

Automatic Core Biopsy Instrument/ Semi-Automatic Core Biopsy Instrument/ Disposable Coaxial Biopsy Needle received FDA 510(k) clearance on 2025-01-24, under 510(k) number K241793.

Who is the listed applicant for Automatic Core Biopsy Instrument/ Semi-Automatic Core Biopsy Instrument/ Disposable Coaxial Biopsy Needle?

The FDA 510(k) record lists Zhejiang Curaway Medical Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Automatic Core Biopsy Instrument/ Semi-Automatic Core Biopsy Instrument/ Disposable Coaxial Biopsy Needle?

The FDA product code for Automatic Core Biopsy Instrument/ Semi-Automatic Core Biopsy Instrument/ Disposable Coaxial Biopsy Needle is KNW.

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Otros registros que enlistan a Zhejiang Curaway Medical Technology Co., Ltd. como solicitante

K260517Automatic Core Biopsy Instrument K244018Disposable Biopsy Needle K242322Bone Marrow Biopsy Needle K240758Radiofrequency Generator System, Cura RF Electrode K232505Endovenous Radiofrequency Generator, Endovenous Radiofrequency Catheter K222001Irreversible Electroporation Ablation Generator, Irreversible Electroporation Probe

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Dispositivos relacionados (Código: KNW)

K260517Automatic Core Biopsy InstrumentZhejiang Curaway Medical Technology Co., Ltd.K262571EnCor EnCompass™ Breast Biopsy and Tissue Removal SystemBard Peripheral Vascular, Inc.K262792Brevera Biopsy System with CorLumina Imaging Technology (BREVDISP09)Hologic, Inc.K260572Marrow MarxmanMedimetrix, LLC K261196Promisemed VeriEcto Automatic Biopsy NeedlesPromisemed Hangzhou Meditech Co., Ltd.K260365Mammotome Prima™ MR Dual Vacuum-Assisted Breast Biopsy System Control Module; Mammotome Prima™ MR Dual Vacuum-Assisted Breast Biopsy System Disposable Probe, 8 gauge; Mammotome Prima™ MR Dual Vacuum-Assisted Breast Biopsy System Disposable Targeting Set, 8 gauge; Mammotome Prima™ MR Dual Vacuum-Assisted Breast Biopsy System Foot Switch; Mammotome Prima™ MR Dual Vacuum-Assisted Breast Biopsy System Reusable Tray; Mammotome Prima™ MR Dual Vacuum-Assisted Breast Biopsy System Battery CharDevicor Medical Products, Inc.

Fuente oficial

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