FDA 510(k)

Concorde Models Concorde US and Concorde ST Soft Tissue Biopsy Devices

N.º K: K201244 · 2020-08-07

Fecha de decisión2020-08-07

Código de productoKNW

Comité asesorGU

DecisiónSubstantially Equivalent

Resumen del dispositivo

Concorde Models Concorde US and Concorde ST Soft Tissue Biopsy Devices is the device name listed in this FDA 510(k) record. The listed applicant is Transmed7, LLC. It received FDA 510(k) clearance on 2020-08-07 under 510(k) number K201244. 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 Concorde Models Concorde US and Concorde ST Soft Tissue Biopsy Devices?

Concorde Models Concorde US and Concorde ST Soft Tissue Biopsy Devices is a medical device that received FDA 510(k) clearance on 2020-08-07. The listed applicant is Transmed7, LLC. The 510(k) number is K201244.

When did Concorde Models Concorde US and Concorde ST Soft Tissue Biopsy Devices receive FDA 510(k) clearance?

Concorde Models Concorde US and Concorde ST Soft Tissue Biopsy Devices received FDA 510(k) clearance on 2020-08-07, under 510(k) number K201244.

Who is the listed applicant for Concorde Models Concorde US and Concorde ST Soft Tissue Biopsy Devices?

The FDA 510(k) record lists Transmed7, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Concorde Models Concorde US and Concorde ST Soft Tissue Biopsy Devices?

The FDA product code for Concorde Models Concorde US and Concorde ST Soft Tissue Biopsy Devices is KNW.

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Otros registros que enlistan a Transmed7, LLC como solicitante

K173316SpeedBird Model SB38 Soft Tissue Biopsy Device; SpeedBird Model SBU Soft Tissue Biopsy Device; SpeedBird Model SBU99 Soft Tissue Biopsy Device

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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