510(k) Report

Devices descending from K131157

12 later devices reach Ranfac Bone Marrow Aspiration Needle through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K260572Marrow MarxmanMedimetrix, LLC20260—
+1K243945ALARA BMA Neuro Access Kit (ALARA BMAN and ALARA BMAC Kit)SurGenTec, LLC20250—
+1K240664ALARA BMA Neuro Access Kit (ALARA BMAN and ALARA BMAC Kit)SurGenTec, LLC20241—
+1K213213Arthrex Vortex Threaded Bone Marrow Recovery NeedleArthrex, Inc.20210—
+1K190177J-Type Marrow Biopsy Needle,T-Type Marrow Biopsy Needle,Tweezer Bone Marrow Biopsy Needle,Ranfac Corporation20190—
+1K183146Ranfac Cartilage Biopsy NeedleRanfac Corporation20190—
+1K180807Celling Aspiration NeedleSpine Smith Holdings, LLC20180—
+1K150563Marrow Cellution Bone Marrow Aspiration NeedleRanfac, Corp.20154—
+1K140991Ranfac Aspiration Needle with Adjustable GuideRanfac, Corp.20145—
+2K223612Ranfac Lateral Access Bone Marrow Aspiration Needle (CRVS-BMA-LA)Ranfac Corporation20231—
+2K203397Marrow-Pack (white)- 11gauge/10cm or 13gauge/10cm, Marrow-Tray (red)- 11gauge/10cm or…Biopsybell S.R.L.20210—
+2K202287Ran-Flex-B Bone Marrow Aspiration NeedleRanfac Corporation20201—