510(k) Report

Devices descending from K021999

21 later devices reach Gripper Plus Needle through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K063631Polyperf / Polyperf SafeLaboratoires Perouse20071—
+1K070116Power Port-a-Cath and Power Port-a-Cath II; Implantable Venous Access Systems and Power…Smiths Medical MD, Inc.200718—
+2K120261PPS PI Pressure Injectable Safety Huber Needle Without Lateral Injection Site, PPS PI…Perouse Medical20120—
+2K111101Norport CT-PC, Lucent Non-Coring Needel Infusion SetNorfolk Medical20112—
+2K093414Port-a-Cath Power P.a.C. Implantable Venous Access SystemsSmiths Medical Asd, Inc.201001
+2K073050Safestep Max Power-Injectable Infusion SetSpecialized Health Products International, Inc.2008132
+3K170897Surecan Safety II Needle, Surecan Safety II Needle, Surecan Safety II Needle with…B.Braun Medical, Inc.20176—
+3K153440PowerLoc MAX Power Injectable Infusion Set, SafeStep Huber Needle SetC.R. Bard, Inc.2016212
+3K112713Norfolk Medical-Sportport-Family of PortsNorfolk Medical Products, Inc.20111—
+3K090809MPS Acacia Power Injectable Infusion SetMps Acacia20092—
+4K230715Promisemed Safety Huber NeedlePromisemed Hangzhou Meditech Co., Ltd.20232—
+4K200463Huber Needle Infusion Set, Safety Huber Needle Infusion SetJiangsu Caina Medical Co.,Ltd20212—
+4K192291TidalPort-AP Implantable Apheresis Vascular Access PortNorfolk Medical Products, Inc.20200—
+4K171735PowerLoc MAX Power-Injectable Infusion Set and SafeStep Huber Needle SetC.R. Bard, Inc.20171—
+4K142527Extension Set with BD Q-Syte Luer Access Split SeptumAcacia, Inc.20141—
+5K25409525G Huber NeedleMartech Medical Products20260—
+5K243332Promisemed Safety Huber NeedlesPromisemed Hangzhou Meditech Co., Ltd.20251—
+5K241353PowerLoc™ Max Power Injectable Infusion Set; SafeStep™ Huber Needle SetBard Access Systems, Inc.20240—
+5K211121Intera Non-coring (Huber) Refill Needles, Intera Non-coring (Huber) Special bolus…Intera Oncology, Inc.20210—
+5K202672Precision Delivery Infusion SetQuest Medical, Inc.202101
+6K251138Promisemed Safety Huber NeedlesPromisemed Hangzhou Meditech Co., Ltd.20250—