510(k) Report

Devices descending from K133948

27 later devices reach Bard (R) Monopty (R) Disposable Core Biopsy Instrument, Bard (R) Max-Core (R)… through their predicates, nearest generation first.

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