FDA 510(k)

Uramix CuraWay Biopsy Needle

Номер K: K203141 · 2021-09-17

ЗаявительUramix, Inc.

Дата решения2021-09-17

Код продуктаKNW

Консультативный комитетGU

РешениеSubstantially Equivalent

Описание устройства

Uramix CuraWay Biopsy Needle is the device name listed in this FDA 510(k) record. The listed applicant is Uramix, Inc.. It received FDA 510(k) clearance on 2021-09-17 under 510(k) number K203141. The device is classified under product code KNW. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Часто задаваемые вопросы

What is the Uramix CuraWay Biopsy Needle?

Uramix CuraWay Biopsy Needle is a medical device that received FDA 510(k) clearance on 2021-09-17. The listed applicant is Uramix, Inc.. The 510(k) number is K203141.

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

Uramix CuraWay Biopsy Needle received FDA 510(k) clearance on 2021-09-17, under 510(k) number K203141.

Who is the listed applicant for Uramix CuraWay Biopsy Needle?

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

What is the FDA product code for Uramix CuraWay Biopsy Needle?

The FDA product code for Uramix CuraWay Biopsy Needle is KNW.

Связанные клинические исследования

Связанные записи сопоставляются автоматически на основании названий, кодов продукции или иных метаданных. Сопоставление не подтверждает клиническую, научную, корпоративную или регуляторную связь; ознакомьтесь с официальными источниками по ссылкам.

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Связанные устройства (Код: 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.

Официальный источник

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