510(k) Report

Devices descending from K922939

31 later devices reach Bard Monopty Disposable Core Biopsy Isnt. W/ Cent. through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K150169Sertera Biopsy DeviceHologic, Inc.201503
+1K133948Bard (R) Monopty (R) Disposable Core Biopsy Instrument, Bard (R) Max-Core (R) Disposable…Bard Peripheral Vascular, Inc.2014277
+1K120440Presto Breast Biopsy DeviceSontina Medical, LLC20121—
+2K243296Disposable Biopsy NeedleCarbon (Shenzhen) Medical Device Co., Ltd.20250—
+2K250032Marquee™ Disposable Core Biopsy Instrument and Instrument KitBard Peripheral Vascular, Inc.20250—
+2K241793Automatic Core Biopsy Instrument/ Semi-Automatic Core Biopsy Instrument/ Disposable…Zhejiang Curaway Medical Technology Co., Ltd.20250—
+2K222865M Biopsy /SureCore Automatic Disposable Biopsy Needle, M Biopsy /SureCore Semi-Automatic…Canyon Medical, Inc.20231—
+2K220611SUREcore Plus Biopsy InstrumentUro-1, Inc.20220—
+2K214063Model 121 Biopsy Needle, Model 111 Biopsy Needle, Model 112 Biopsy Needle, and Model 131…Guangzhou Shengwei Medical Devices Co., Ltd.20220—
+2K212079TeesuVac Breast Biopsy Device Mark 1Teesuvac Aps20220—
+2K212284Disposable Automatic Core Biopsy InstrumentSuzhou Leapmed Healthcare Corporation20210—
+2K203141Uramix CuraWay Biopsy NeedleUramix, Inc.20210—
+2K172344Medax Biopsy Systems II (MEDONE, MEDCUT, MEDEM, MEDBONE, MEDLOCK)Medax Srl Unipersonale20171—
+2K171953Bard Mission Disposable Core Biopsy InstrumentBard Peripheral Vascular, Inc.201753
+2K153337Corvocet Biopsy SystemMerit Medical Systems, Inc.20162—
+2K141552Achieve Programmable Auomated Biopsy SystemsCare Fusion201411—
+2K133702Presto Breast Biopsy DeviceSontina Medical, LLC20140—
+3K243095Mammotome AutoCore™ Single Insertion Core Biopsy SystemDevicor Medical Products, Inc.20240—
+3K233031M·Biopsy /SureCore Automatic Disposable Biopsy Needle, M·Biopsy /SureCore Semi-automatic…Canyon Medical, Inc.20240—
+3K201166Temno Elite Biopsy SystemMerit Medical Systems, Inc.20200—
+3K192101Medone Ultra, MedextraMedax Srl Unipersonale20202—
+3K192099MED-I Bone Marrow Aspiration Needle, MED-S Bone Marrow Aspiration Needle, MED-L Bone…Medax Srl Unipersonale20200—
+3K191472Biopsy NeedleUshare Medical, Inc.20200—
+3K180450Corvocet Biopsy SystemMerit Medical Systems, Inc.201812
+3K160316SemiCut Semi-automatic Biopsy Needle, Themy Automatic Disposable Biopsy Device, Palium…M.D.L. S.R.L.201641
+4K260517Automatic Core Biopsy InstrumentZhejiang Curaway Medical Technology Co., Ltd.20260—
+4K212820Disposable Semi Automatic Biopsy InstrumentSuzhou Leapmed Healthcare Corporation20220—
+4K212822Disposable Coaxial Biopsy NeedleSuzhou Leapmed Healthcare Corporation20220—
+4K212819Disposable Biopsy Refill NeedleSuzhou Leapmed Healthcare Corporation20220—
+4K210946Promisemed Automatic Biopsy Needles, Promisemed Co-Axial Biopsy Devices, Promisemed…Promisemed Hangzhou Meditech Co., Ltd.20211—
+5K261196Promisemed VeriEcto Automatic Biopsy NeedlesPromisemed Hangzhou Meditech Co., Ltd.20260—