510(k) Report

Devices descending from K011122

7 later devices reach Ballpen Spinal Needle W/WO Introducer through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K112515Pencan Spinal NeedleB.Braun Medical, Inc.20116—
+2K170900DASH 6 NRFit Lock Syringe + Accessories, DASH 6 NRFit Slip Syringe + Accessories, DASH 6…Intervene Group, Ltd.20171—
+2K141126Uniever Disposable Spinal Anesthesia NeedleUnisis Corp.20143—
+3K201031NRFit® Caps, Male and Female Neuraxial Tip CapsInternational Medical Industries, Inc.20200—
+3K171518Epidural Anesthesia Needles, Spinal Anesthesia Needles, Combined Anesthesia NeedlesZhejiang Kindly Medical Devices Co., Ltd.20182—
+4K212982Medispine - Spinal Needle, Glospine - Spinal NeedleGlobal Medikit Limited20220—
+4K211085BD Perisafe Tuohy Epidural Needle, BD Perisafe Weiss Epidural NeedleBecton, Dickinson and Company20220—