510(k) Report

Devices descending from K911260

40 later devices reach Atraumatic Standard Sprotte Needle through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K173155Pakter Curved Needle SetCook Incorporated20181—
+1K160294SPROTTE NRFit, Quincke NRFit Lumbar Puncture needlesPAJUNK GmbH Medizintechnologie20163—
+1K060563Epispin, Epispin II Safety, Epispin II, Epispin I, Epispin IVPajunk GmbH20061—
+1K040965Pajunk Tuohy Needles, Quincke Needles, Chiba Needles & Crawford NeedlesPajunk GmbH200436—
+1K041843Pencil Point NeedleEpimed International, Inc.200491
+2K250774SPROTTE® STANDARD (LUER/ NRFit®) Lumbar PuncturePAJUNK GmbH Medizintechnologie20250—
+2K212328DiscCath Needle SetDisccath, LLC20210—
+2K193131BD Quincke Spinal NRFit Needle, BD Whitacre Spinal NRFit Needle, BD Spinal Introducer…Becton, Dickinson and Company20200—
+2K170112IMD's Lumbar Puncture NeedleInternational Medical Development, Inc.(Imd)20180—
+2K160297Tuohy NRFitPAJUNK GmbH Medizintechnologie20160—
+2K160295SPROTTE NRFit, Quincke NRFitPAJUNK GmbH Medizintechnologie20161—
+2K142553UNIEVER Disposable Epidural Anesthesia Needle, UNIEVER Disposable Nerve Blocked NeedleUnisis Corp.20153—
+2K113207Sono Tap, Tuohy SonoPajunk GmbH201211—
+2K082183Pajunk's Generic Convenience Tray for Regional Anesthesia: CSFPAJUNK GmbH Medizintechnologie20080—
+2K080140Laurimed Spinal Injection SystemLaurimed, LLC20082—
+2K070354Imd's Anesthesia Needles (Tuohy, Quincke and Pencil Point)International Medical Development, Inc.20077—
+2K062900Pajunks Stimulong Tsui-Method SetPAJUNK GmbH Medizintechnologie20072—
+2K052946MPS Acacia Nerve Block NeedleMps Acacia20051—
+2K043500Functional Anaesthetic Discography (Fad) System, Including Fad Catheter Kit and Fad…Innospine, Inc.200531
+3K243690SonoMSKPAJUNK GmbH Medizintechnologie20250—
+3K243525SonoTAP and SonoTAP IIPAJUNK GmbH Medizintechnologie20250—
+3K241953SPROTTE® STANDARD (LUER/ NRFit®) AnesthesiologyPAJUNK GmbH Medizintechnologie20240—
+3K171968EchoGlo NeedleSmiths Medical Asd, Inc.20180—
+3K171518Epidural Anesthesia Needles, Spinal Anesthesia Needles, Combined Anesthesia NeedlesZhejiang Kindly Medical Devices Co., Ltd.20182—
+3K163292Sonic Block Tuohy, Sonic Block Quincke, Sonic Block Chiba, Sonic Block CrawfordSpectra Medical Devices20170—
+3K163216Pinpoint GT NeedlesC.R. Bard, Inc.20170—
+3K133632Perican UltraB.Braun Medical, Inc.20141—
+3K131006Anesthesia Conduction NeedlesLccs Products Limited20135—
+3K120475Anesthesia Conduction NeedlesShanghai Samedical & Plastic Instruments Co., Ltd.20120—
+3K113662Fenestrated Nerve Block NeedleImd, Inc.20120—
+3K083909Spinal Injection SystemLaurimed, LLC20091—
+3K082164Pajunk's Generic Convenience Tray for Regional Anesthesia of the Peripheral Plexus…PAJUNK GmbH Medizintechnologie20080—
+3K073516Discyphor Direct Catheter System, Discyphor Direct Needles, Long, Discyphor Direct…Kyphon, Inc.20080—
+3K063071Discyphor Catheter System, Model D01A; Discyphor Introducer Needle, Model D01BKyphon, Inc.20071—
+3K061210Functional Anaesthetic Discography (Fad) Catheter System, Model D01A ; Introducer…Kyphon, Inc.20062—
+4K212982Medispine - Spinal Needle, Glospine - Spinal NeedleGlobal Medikit Limited20220—
+4K211085BD Perisafe Tuohy Epidural Needle, BD Perisafe Weiss Epidural NeedleBecton, Dickinson and Company20220—
+4K190026Arrow Epidural Needle KZ-05500-007(Luer); KZ-05500-009 (NRFit)Teleflex Medical20190—
+4K150266Remington Medical Inc. Tuohy Epidural NeedlesRemington Medical, Inc.20150—
+4K091818Laurimed Spinal Injection SystemLaurimed, LLC20090—