510(k) Report

Devices descending from K112515

6 later devices reach Pencan Spinal Needle through their predicates, nearest generation first.

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