VMCore Biopsy Needle — 510(k) da FDA K201650

Resumo do dispositivo

VMCore Biopsy Needle is the device name listed in this FDA 510(k) record. The listed applicant is Uro-1, Inc.. It received FDA 510(k) clearance on 2021-01-15 under 510(k) number K201650. The device is classified under product code KNW. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the VMCore Biopsy Needle?

VMCore Biopsy Needle is a medical device that received FDA 510(k) clearance on 2021-01-15. The listed applicant is Uro-1, Inc.. The 510(k) number is K201650.

When did VMCore Biopsy Needle receive FDA 510(k) clearance?

VMCore Biopsy Needle received FDA 510(k) clearance on 2021-01-15, under 510(k) number K201650.

Who is the listed applicant for VMCore Biopsy Needle?

The FDA 510(k) record lists Uro-1, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VMCore Biopsy Needle?

The FDA product code for VMCore Biopsy Needle is KNW.

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Outros registros que listam Uro-1, Inc. como candidato(a)

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Dispositivos Relacionados (Código: KNW)

Registros relacionados são pareados automaticamente usando nomes, códigos de produtos ou outros metadados. Um pareamento não estabelece um vínculo clínico, científico, corporativo ou regulatório verificado; revise as fontes oficiais vinculadas.

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.

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