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510(k) K214063

Device
Model 121 Biopsy Needle, Model 111 Biopsy Needle, Model 112 Biopsy Needle, And Model 131 Disposable Coaxial Biopsy Needle
Applicant
Guangzhou Shengwei Medical Devices Co., Ltd
510(k) number
K214063
Product code
KNW  
Decision
Substantially Equivalent (SESE)
Decision date
2022-06-03
Date received
2021-12-27
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
Xiaojun Cai
Address
# 126, Guangshao Rd., Aotou Town Conghua City CN 510900 510900

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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