FDA 510(k)

Mammotome AutoCore™ Single Insertion Core Biopsy System

Numéro K : K243095 · 2024-10-29

Date de décision2024-10-29

Code produitKNW

Comité consultatifGU

DécisionSubstantially Equivalent

Résumé du dispositif

Mammotome AutoCore™ Single Insertion Core Biopsy 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 2024-10-29 under 510(k) number K243095. The device is classified under product code KNW. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the Mammotome AutoCore™ Single Insertion Core Biopsy System?

Mammotome AutoCore™ Single Insertion Core Biopsy System is a medical device that received FDA 510(k) clearance on 2024-10-29. The listed applicant is Devicor Medical Products, Inc.. The 510(k) number is K243095.

When did Mammotome AutoCore™ Single Insertion Core Biopsy System receive FDA 510(k) clearance?

Mammotome AutoCore™ Single Insertion Core Biopsy System received FDA 510(k) clearance on 2024-10-29, under 510(k) number K243095.

Who is the listed applicant for Mammotome AutoCore™ Single Insertion Core Biopsy 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 AutoCore™ Single Insertion Core Biopsy System?

The FDA product code for Mammotome AutoCore™ Single Insertion Core Biopsy System is KNW.

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Autres dossiers indiquant Devicor Medical Products, Inc. en tant que demandeur

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)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 K212158HydroMARK Breast Biopsy Site Marker

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Dispositifs connexes (Code : 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.

Source officielle

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