FDA 510(k)

Mammotome Revolve Dual Vacuum Assisted Biopsy (VAB) System

N.º K: K202012 · 2020-08-18

SolicitanteDevicor Medical Products, Inc.

Fecha de decisión2020-08-18

Código de productoKNW

Comité asesorGU

DecisiónSubstantially Equivalent

Resumen del dispositivo

Mammotome Revolve Dual Vacuum Assisted Biopsy (VAB) System is the device name listed in this FDA 510(k) record. The listed applicant is Devicor Medical Products, Inc.. It received FDA 510(k) clearance on 2020-08-18 under 510(k) number K202012. 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 Mammotome Revolve Dual Vacuum Assisted Biopsy (VAB) System?

Mammotome Revolve Dual Vacuum Assisted Biopsy (VAB) System is a medical device that received FDA 510(k) clearance on 2020-08-18. The listed applicant is Devicor Medical Products, Inc.. The 510(k) number is K202012.

When did Mammotome Revolve Dual Vacuum Assisted Biopsy (VAB) System receive FDA 510(k) clearance?

Mammotome Revolve Dual Vacuum Assisted Biopsy (VAB) System received FDA 510(k) clearance on 2020-08-18, under 510(k) number K202012.

Who is the listed applicant for Mammotome Revolve Dual Vacuum Assisted Biopsy (VAB) System?

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

What is the FDA product code for Mammotome Revolve Dual Vacuum Assisted Biopsy (VAB) System?

The FDA product code for Mammotome Revolve Dual Vacuum Assisted Biopsy (VAB) System is KNW.

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Otros registros que enlistan a Devicor Medical Products, Inc. como solicitante

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 Char K253761HydroMARK™ Plus Breast Biopsy Site Marker (Dragonfly Shape); HydroMARK™ Plus Breast Biopsy Site Marker (Hummingbird Shape)K243095Mammotome AutoCore™ Single Insertion Core Biopsy System K240527HydroMARK™ Plus Breast Biopsy Site Marker (Hummingbird Shape) (4010-02-15-T6)K232615LumiMARK™ Biopsy Site Marker (LM0215T (Tulip Shape)); LumiMARK™ Biopsy Site Marker (LM0215L (Lotus Shape)); LumiMARK™ Biopsy Site Marker (LM0215R (Rose shape))K221961HydroMARK Plus Breast Biopsy Site Marker

Ver todos los 14 dispositivos →

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

Ver en la base de datos de la FDA →

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