FDA 510(k)

Möller Medical Biopsy Needles and Systems

Номер K: K162588 · 2017-06-19

Дата решения2017-06-19

Код продуктаKNW

Консультативный комитетGU

РешениеSubstantially Equivalent

Описание устройства

Möller Medical Biopsy Needles and Systems is the device name listed in this FDA 510(k) record. The listed applicant is Moller Medical GmbH. It received FDA 510(k) clearance on 2017-06-19 under 510(k) number K162588. 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 Möller Medical Biopsy Needles and Systems?

Möller Medical Biopsy Needles and Systems is a medical device that received FDA 510(k) clearance on 2017-06-19. The listed applicant is Moller Medical GmbH. The 510(k) number is K162588.

When did Möller Medical Biopsy Needles and Systems receive FDA 510(k) clearance?

Möller Medical Biopsy Needles and Systems received FDA 510(k) clearance on 2017-06-19, under 510(k) number K162588.

Who is the listed applicant for Möller Medical Biopsy Needles and Systems?

The FDA 510(k) record lists Moller Medical GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Möller Medical Biopsy Needles and Systems?

The FDA product code for Möller Medical Biopsy Needles and Systems 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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