510(k) Report

Devices descending from K061570

8 later devices reach I-Style Bone Marrow Aspiration Needle through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K121181Swannshidi Bone Marrow Aspiration NeedleAlliance Partners, LLC20126—
+1K120002I-Style Bone Marrow Aspiration Needle with T-HandleBusse Hospital Disposables, Inc.20120—
+2K140991Ranfac Aspiration Needle with Adjustable GuideRanfac, Corp.20145—
+3K150563Marrow Cellution Bone Marrow Aspiration NeedleRanfac, Corp.20154—
+4K260572Marrow MarxmanMedimetrix, LLC20260—
+4K223612Ranfac Lateral Access Bone Marrow Aspiration Needle (CRVS-BMA-LA)Ranfac Corporation20231—
+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—