FDA 510(k)

EnCor MRI Introducer Set, EnCor Probe Introducer

Número K: K161805 · 2016-07-19

Data da decisão2016-07-19

Código do produtoKNW

Comité consultivoGU

DecisãoSubstantially Equivalent

Resumo do dispositivo

EnCor MRI Introducer Set, EnCor Probe Introducer is the device name listed in this FDA 510(k) record. The listed applicant is Senorx, Inc.. It received FDA 510(k) clearance on 2016-07-19 under 510(k) number K161805. 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 EnCor MRI Introducer Set, EnCor Probe Introducer?

EnCor MRI Introducer Set, EnCor Probe Introducer is a medical device that received FDA 510(k) clearance on 2016-07-19. The listed applicant is Senorx, Inc.. The 510(k) number is K161805.

When did EnCor MRI Introducer Set, EnCor Probe Introducer receive FDA 510(k) clearance?

EnCor MRI Introducer Set, EnCor Probe Introducer received FDA 510(k) clearance on 2016-07-19, under 510(k) number K161805.

Who is the listed applicant for EnCor MRI Introducer Set, EnCor Probe Introducer?

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

What is the FDA product code for EnCor MRI Introducer Set, EnCor Probe Introducer?

The FDA product code for EnCor MRI Introducer Set, EnCor Probe Introducer is KNW.

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Outros registros que listam Senorx, Inc. como candidato(a)

K233220EnCor Enspire™Breast Biopsy System (E4115, E4230); EnCor™ Breast Biopsy Driver (DRENCOR); EnCor™ MRI Breast Biopsy Driver (DRENCORMR); EnCor™ Breast Biopsy Driver Probes (ECP017G, ECP017GV, ECP0110G, ECP0110GV, ECP0112G, ECP0112GV); EnCor™ MRI Breast Biopsy Probes (ECPMR017G, ECPMR0110G, ECPMR0110GBT)K210654EnCor Breast Biopsy Probe with Rinse Tube

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.

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