FDA 510(k)

Marrow Marxman

Номер K: K260572 · 2026-08-04

Дата решения2026-08-04

Код продуктаKNW

Консультативный комитетGU

РешениеSubstantially Equivalent

Описание устройства

Marrow Marxman is the device name listed in this FDA 510(k) record. The listed applicant is Medimetrix, LLC. It received FDA 510(k) clearance on 2026-08-04 under 510(k) number K260572. 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 Marrow Marxman?

Marrow Marxman is a medical device that received FDA 510(k) clearance on 2026-08-04. The listed applicant is Medimetrix, LLC. The 510(k) number is K260572.

When did Marrow Marxman receive FDA 510(k) clearance?

Marrow Marxman received FDA 510(k) clearance on 2026-08-04, under 510(k) number K260572.

Who is the listed applicant for Marrow Marxman?

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

What is the FDA product code for Marrow Marxman?

The FDA product code for Marrow Marxman 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.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.K252795ZeniCore™ Automatic Biopsy Instrument (863212100 / ZeniCore Automatic Biopsy Device 12ga x 10cm with Coaxial Introducer Kit); ZeniCore™ Automatic Biopsy Instrument (863212130 / ZeniCore Automatic Biopsy Device 12ga x 13cm with Coaxial Introducer Kit); ZeniCore™ Automatic Biopsy Instrument (863214100 / ZeniCore Automatic Biopsy Device 14ga x 10cm with Coaxial Introducer Kit); ZeniCore™ Automatic Biopsy Instrument (863214130 / ZeniCore Automatic Biopsy Device 14ga x 13cm with CoaxialArgon Medical Devices, Inc.

Официальный источник

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