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510(k) K192099

Device
MED-I Bone Marrow Aspiration Needle, MED-S Bone Marrow Aspiration Needle, MED-L Bone Marrow Biopsy And Aspiration System, MED-B Bone Marrow Biopsy System, MED-J Bone Marrow Biopsy And Aspiration System
Applicant
Medax Srl Unipersonale
510(k) number
K192099
Product code
KNW  
Decision
Substantially Equivalent (SESE)
Decision date
2020-04-02
Date received
2019-08-05
Regulation
876.1075
Classification name
Instrument, Biopsy
Medical specialty
Gastroenterology/Urology
Review panel
General & Plastic Surgery
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Stefano Cavalieri
Address
Via R.Piva, 1/A Poggio Rusco IT 46025 46025

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code KNW  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K260517Automatic Core Biopsy InstrumentZhejiang Curaway Medical Technology Co., Ltd.2026-08-28
K262571EnCor EnCompass™ Breast Biopsy and Tissue Removal SystemBard Peripheral Vascular, Inc.2026-08-14
K262792Brevera Biopsy System with CorLumina Imaging Technology (BREVDISP09)Hologic, Inc.2026-08-12
K260572Marrow MarxmanMedimetrix, LLC2026-08-04
K261196Promisemed VeriEcto Automatic Biopsy NeedlesPromisemed Hangzhou Meditech Co., Ltd.2026-05-12
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.2026-03-04
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.2026-02-23
K252681EnCor EnCompass™ Breast Biopsy and Tissue Removal SystemBard Peripheral Vascular, Inc.2025-12-12
K252183Resitu Slider 09 (RESL09)Resitu Medical AB2025-09-24
K243407Forcyte Autograft Harvest KitForcyte Medical, LLC2025-07-29
K244018Disposable Biopsy NeedleZhejiang Curaway Medical Technology Co., Ltd.2025-07-22
K243296Disposable Biopsy NeedleCarbon (Shenzhen) Medical Device Co., Ltd.2025-07-11
K250032Marquee™ Disposable Core Biopsy Instrument and Instrument KitBard Peripheral Vascular, Inc.2025-07-10
K243886ExpressCore Biopsy DeviceInrad, Inc.2025-04-29
K243945ALARA BMA Neuro Access Kit (ALARA BMAN and ALARA BMAC Kit)SurGenTec, LLC2025-04-24

Legacy Summary#

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FDA Review#

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