510(k) Report

Devices descending from K974814

30 later devices reach Manan (TM) Super-Core Biopsy Needles through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K213232NovaCore Semi-Automatic Biopsy InstrumentArgon Medical Devices20220—
+1K161409M-Biopsy Semi-Automatic Biopsy Instrument M-Biopsy Coaxial Introducer Needle for SemMermaid Medical A/S20166—
+1K052435Pneumrx Family of Biopsy Needles and KitsPneumrx, Inc.20050—
+1K052802Manan Bio-Cut Soft Tissue Biopsy NeedleManan Medical Products, Inc.20051—
+1K051506Mielo-Can, Best-Lisas, Ben - Bone Biopsy. Fast-Cut, Colt, Spring-Cut, Bio-Cut - Soft…Sterylab S.R.L.200518—
+2K171953Bard Mission Disposable Core Biopsy InstrumentBard Peripheral Vascular, Inc.201753
+2K131157Ranfac Bone Marrow Aspiration NeedleRanfac, Corp.201312—
+2K080674Pajunk's Primocut Disposable Biopsy SystemPAJUNK GmbH Medizintechnologie20080—
+2K070759Powered EZ-IO Pediatric Bone Marrow Aspiration SystemVidacare Corporation20073—
+2K070179Trokabone, Trokabone SternalPAJUNK GmbH Medizintechnologie20070—
+3K260572Marrow MarxmanMedimetrix, LLC20260—
+3K250032Marquee™ Disposable Core Biopsy Instrument and Instrument KitBard Peripheral Vascular, Inc.20250—
+3K243945ALARA BMA Neuro Access Kit (ALARA BMAN and ALARA BMAC Kit)SurGenTec, LLC20250—
+3K241793Automatic Core Biopsy Instrument/ Semi-Automatic Core Biopsy Instrument/ Disposable…Zhejiang Curaway Medical Technology Co., Ltd.20250—
+3K240664ALARA BMA Neuro Access Kit (ALARA BMAN and ALARA BMAC Kit)SurGenTec, LLC20241—
+3K222865M Biopsy /SureCore Automatic Disposable Biopsy Needle, M Biopsy /SureCore Semi-Automatic…Canyon Medical, Inc.20231—
+3K213213Arthrex Vortex Threaded Bone Marrow Recovery NeedleArthrex, Inc.20210—
+3K201166Temno Elite Biopsy SystemMerit Medical Systems, Inc.20200—
+3K190177J-Type Marrow Biopsy Needle,T-Type Marrow Biopsy Needle,Tweezer Bone Marrow Biopsy Needle,Ranfac Corporation20190—
+3K183146Ranfac Cartilage Biopsy NeedleRanfac Corporation20190—
+3K180807Celling Aspiration NeedleSpine Smith Holdings, LLC20180—
+3K150563Marrow Cellution Bone Marrow Aspiration NeedleRanfac, Corp.20154—
+3K142377The OnControl Bone Marrow Biopsy System by VidacareVidacare, LLC201424
+3K140991Ranfac Aspiration Needle with Adjustable GuideRanfac, Corp.20145—
+4K233031M·Biopsy /SureCore Automatic Disposable Biopsy Needle, M·Biopsy /SureCore Semi-automatic…Canyon Medical, Inc.20240—
+4K230015OmniBone™ Bone Marrow Biopsy Kit with Power Driver, OmniBone™ Bone Biopsy Kit with Power…Laurane Medical Sas20230—
+4K223612Ranfac Lateral Access Bone Marrow Aspiration Needle (CRVS-BMA-LA)Ranfac Corporation20231—
+4K213896BD Trek Powered Bone Biopsy SystemBard Peripheral Vascular20220—
+4K203397Marrow-Pack (white)- 11gauge/10cm or 13gauge/10cm, Marrow-Tray (red)- 11gauge/10cm or…Biopsybell S.R.L.20210—
+4K202287Ran-Flex-B Bone Marrow Aspiration NeedleRanfac Corporation20201—