510(k) Report

Devices descending from K895897

26 later devices reach Manan Prostatic Biopsy Needle through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K981166Accucore Core Biopsy Needle Catalog Codes:581014, 581614, 581618, 582018, 582518…Inrad19982—
+1K980226Manan Pro-Mag Automatic Biopsy SystemMedical Device Technologies, Inc.1998221
+2K230646SUREcore Prime Biopsy InstrumentUro-1 Medical, Inc.20230—
+2K162588Möller Medical Biopsy Needles and SystemsMoller Medical GmbH20171—
+2K052435Pneumrx Family of Biopsy Needles and KitsPneumrx, Inc.20050—
+2K051506Mielo-Can, Best-Lisas, Ben - Bone Biopsy. Fast-Cut, Colt, Spring-Cut, Bio-Cut - Soft…Sterylab S.R.L.200518—
+2K013109SonopsyHakko Medical Co., Ltd.20020—
+3K242128Forsvall biopsy needle system for prostate biopsy (Forsvall biopsy gun and Forsvall…Xaga Surgical20250—
+3K131157Ranfac Bone Marrow Aspiration NeedleRanfac, Corp.201312—
+3K070759Powered EZ-IO Pediatric Bone Marrow Aspiration SystemVidacare Corporation20073—
+3K070179Trokabone, Trokabone SternalPAJUNK GmbH Medizintechnologie20070—
+4K260572Marrow MarxmanMedimetrix, LLC20260—
+4K243945ALARA BMA Neuro Access Kit (ALARA BMAN and ALARA BMAC Kit)SurGenTec, LLC20250—
+4K240664ALARA BMA Neuro Access Kit (ALARA BMAN and ALARA BMAC Kit)SurGenTec, LLC20241—
+4K213213Arthrex Vortex Threaded Bone Marrow Recovery NeedleArthrex, Inc.20210—
+4K190177J-Type Marrow Biopsy Needle,T-Type Marrow Biopsy Needle,Tweezer Bone Marrow Biopsy Needle,Ranfac Corporation20190—
+4K183146Ranfac Cartilage Biopsy NeedleRanfac Corporation20190—
+4K180807Celling Aspiration NeedleSpine Smith Holdings, LLC20180—
+4K150563Marrow Cellution Bone Marrow Aspiration NeedleRanfac, Corp.20154—
+4K142377The OnControl Bone Marrow Biopsy System by VidacareVidacare, LLC201424
+4K140991Ranfac Aspiration Needle with Adjustable GuideRanfac, Corp.20145—
+5K230015OmniBone™ Bone Marrow Biopsy Kit with Power Driver, OmniBone™ Bone Biopsy Kit with Power…Laurane Medical Sas20230—
+5K223612Ranfac Lateral Access Bone Marrow Aspiration Needle (CRVS-BMA-LA)Ranfac Corporation20231—
+5K213896BD Trek Powered Bone Biopsy SystemBard Peripheral Vascular20220—
+5K203397Marrow-Pack (white)- 11gauge/10cm or 13gauge/10cm, Marrow-Tray (red)- 11gauge/10cm or…Biopsybell S.R.L.20210—
+5K202287Ran-Flex-B Bone Marrow Aspiration NeedleRanfac Corporation20201—