510(k) Report

Devices descending from K000722

40 later devices reach Unipolar Needles through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K173110GraftsiteSummit Medical, Ltd.20180—
+1K100992NeuralmasInnovative Surgical Solutions, LLC ("Iss")20106—
+1K063380Echostim Facet TipHavel'S, Inc.200711—
+1K062900Pajunks Stimulong Tsui-Method SetPAJUNK GmbH Medizintechnologie20072—
+1K053283Uniplex Nanoline Cannula, Plexolong Nanoline Set, Stimulong Nanoline SetPajunk GmbH20062—
+1K043130Modification to Pajunk Stimulong Plus Catheter SetsPajunk GmbH20044—
+1K042979Modification to: Plexalong SetsPajunk GmbH20045—
+1K033018Stimulong Plus Catheter Set Model, VariousPajunk GmbH200423—
+1K013041Plexolong SetsPajunk GmbH200232—
+2K202699E-Cath STIM acc. TsuiPAJUNK GmbH Medizintechnologie20200—
+2K173134SENTIO MMG Pedicle Access NeedlesMedos International SARL20181—
+2K151069SPECTRA Disposable Single Lumen Echogenic Injection Anesthesia Conduction NeedleSpectra Medical Devices, Inc.20160—
+2K131304Sentio MMGInnovative Surgical Solutions, LLC ("Iss")20143—
+2K113188Sonolong Sono, Curl Sono, Nanoline, Brand Names Carryingsono/SonolongPAJUNK GmbH Medizintechnologie20120—
+2K100241Contiplex D Continuous Nerve Block Set, Model 331687, 331686, 331685, 331680B.Braun Medical, Inc.20107—
+2K093209Focus ( TM) Echogenic Nerve Stimulating NeedleCook, Inc.20101—
+2K082183Pajunk's Generic Convenience Tray for Regional Anesthesia: CSFPAJUNK GmbH Medizintechnologie20080—
+2K082164Pajunk's Generic Convenience Tray for Regional Anesthesia of the Peripheral Plexus…PAJUNK GmbH Medizintechnologie20080—
+2K063282Contiplex Stim Continuous Nerve Block SetB.Braun Medical, Inc.200713—
+2K060563Epispin, Epispin II Safety, Epispin II, Epispin I, Epispin IVPajunk GmbH20061—
+2K052946MPS Acacia Nerve Block NeedleMps Acacia20051—
+2K023218Modification to Plexolong SetsPajunk GmbH200325—
+3K223438TELIGEN System Peripheral Motor Nerve Stimulation IndicationsMedos International SARL20230—
+3K192914Stimuplex Onvision SystemPhilips Medical Systems Nederland B.V.20200—
+3K173526SENTIO MMG Gen 2Medos International SARL20182—
+3K173763iovera systemMyoscience, Inc.20182—
+3K121846Contiplex C Continuous Peripheral Nerve Block NeedleB.Braun Medical, Inc.20122—
+3K113662Fenestrated Nerve Block NeedleImd, Inc.20120—
+3K101728Focus (TM) Echogenic Nerve Stimulating NeedleCook, Inc.20100—
+3K090995B. Braun Contiplex Continuous Nerve Block SetB.Braun Medical, Inc.200912—
+4K243636Neuralytix iD3 System (NTX-9001)Neuralytix, LLC20251—
+4K220656iovera SystemPacira Biosciences, Inc.20221—
+4K191290Ancora Nerve Block Catheter SetAncora Medical Technology20200—
+4K151072Solo-Dex Fascile Continuous Peripheral Nerve Block Catheter and Needle KitSolo-Dex, Inc.20160—
+4K113059Contiplex FXB.Braun Medical, Inc.20123—
+5K260992iD3 Nav Decompression Probe (NTX-9005); iD3 Ball Tip Stim Probe (NTX-9006); iD3 Nav Ball…Neuralytix20260—
+5K243677iovera° SystemPacira Biosciences, Inc.20240—
+5K231242Perifix FX Catheter; Contiplex FX CatheterB.Braun Medical, Inc.20230—
+5K133632Perican UltraB.Braun Medical, Inc.20141—
+6K150266Remington Medical Inc. Tuohy Epidural NeedlesRemington Medical, Inc.20150—