510(k) Report

Devices descending from K050795

19 later devices reach Imbibe Bone Marrow Aspiration Needle through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K143546Imbibe Aspirating XIA TapsStryker Corporation20150—
+1K140868Stryker Kwic NeedleOrthovita, Inc.20141—
+1K140414Imbibe NeedleOrthovita, Inc.201411
+1K131157Ranfac Bone Marrow Aspiration NeedleRanfac, Corp.201312—
+1K052435Pneumrx Family of Biopsy Needles and KitsPneumrx, Inc.20050—
+2K260572Marrow MarxmanMedimetrix, LLC20260—
+2K243945ALARA BMA Neuro Access Kit (ALARA BMAN and ALARA BMAC Kit)SurGenTec, LLC20250—
+2K240664ALARA BMA Neuro Access Kit (ALARA BMAN and ALARA BMAC Kit)SurGenTec, LLC20241—
+2K213213Arthrex Vortex Threaded Bone Marrow Recovery NeedleArthrex, Inc.20210—
+2K201743ClarifEye R1.0, ClarifEye NeedlePhilips Medical Systems Nederlands B.V.20210—
+2K190177J-Type Marrow Biopsy Needle,T-Type Marrow Biopsy Needle,Tweezer Bone Marrow Biopsy Needle,Ranfac Corporation20190—
+2K183146Ranfac Cartilage Biopsy NeedleRanfac Corporation20190—
+2K180807Celling Aspiration NeedleSpine Smith Holdings, LLC20180—
+2K153306Imbibe NeedleOrthovita, Inc.20150—
+2K150563Marrow Cellution Bone Marrow Aspiration NeedleRanfac, Corp.20154—
+2K140991Ranfac Aspiration Needle with Adjustable GuideRanfac, Corp.20145—
+3K223612Ranfac Lateral Access Bone Marrow Aspiration Needle (CRVS-BMA-LA)Ranfac Corporation20231—
+3K203397Marrow-Pack (white)- 11gauge/10cm or 13gauge/10cm, Marrow-Tray (red)- 11gauge/10cm or…Biopsybell S.R.L.20210—
+3K202287Ran-Flex-B Bone Marrow Aspiration NeedleRanfac Corporation20201—