Needle, Conduction, Anesthetic (W/Wo Introducer)

FDA product code BSP · Class II (moderate risk) · 21 CFR 868.5150 · Anesthesiology

152510(k) clearances
0PMA approvals
14recalls

Manufacturers

510(k) clearances

510(k)DeviceApplicantDecision
K243690SonoMSKBSP · Traditional PAJUNK GmbH Medizintechnologie07/01/2025SE
K243682SonoPlex STIM; SonoPlex IIBSP · Traditional PAJUNK GmbH Medizintechnologie06/27/2025SE
K250774SPROTTE® STANDARD (LUER/ NRFit®) Lumbar PunctureBSP · Traditional PAJUNK GmbH Medizintechnologie06/25/2025SE
K243525SonoTAP and SonoTAP IIBSP · Traditional PAJUNK GmbH Medizintechnologie03/24/2025SE
K241953SPROTTE® STANDARD (LUER/ NRFit®) AnesthesiologyBSP · Traditional PAJUNK GmbH Medizintechnologie11/22/2024SE
K241954SonoBlock; SonoBlock IIBSP · Traditional PAJUNK GmbH Medizintechnologie09/11/2024SE
K240253Reach NeedleBSP · Traditional Aerin Medical, Inc.03/21/2024SE
K212982Medispine - Spinal Needle, Glospine - Spinal NeedleBSP · Traditional Global Medikit Limited07/29/2022SE
K211085BD Perisafe Tuohy Epidural Needle, BD Perisafe Weiss Epidural NeedleBSP · Traditional Becton, Dickinson and Company07/01/2022SE
K210978BD Quincke Spinal Needle, BD Whitacre Spinal Needle, BD Spinal Introducer NeedleBSP · Traditional Becton, Dickinson and Company12/22/2021SE
K203668RELI NRFit Epidural Needles, Phoenix NRFit Epidural Needles, RELI NRFit Spinal Needles…BSP · Traditional Myco Medical Supplies, Inc.09/29/2021SE
K212328DiscCath Needle SetBSP · Traditional Disccath, LLC09/26/2021SE
K193131BD Quincke Spinal NRFit Needle, BD Whitacre Spinal NRFit Needle, BD Spinal Introducer…BSP · Traditional Becton, Dickinson and Company09/29/2020SE
K192914Stimuplex Onvision SystemBSP · Traditional Philips Medical Systems Nederland B.V.05/27/2020SE
K191290Ancora Nerve Block Catheter SetBSP · Traditional Ancora Medical Technology02/06/2020SE
K190026Arrow Epidural Needle KZ-05500-007(Luer); KZ-05500-009 (NRFit)BSP · Traditional Teleflex Medical08/21/2019SE
K183316Dr J Spinal and Epidural NeedlesBSP · Traditional Dr. Japan Co., Ltd.08/12/2019SE
K172823Portex NRFit Epidural NeedlesBSP · Traditional Smiths Medical Asd, Inc.06/12/2018SE
K173155Pakter Curved Needle SetBSP · Traditional Cook Incorporated06/07/2018SE
K172410Portex NRFit Epidural Needles, Portex NRFit Spinal Needles, Portex NRFit Loss of…BSP · Traditional Smiths Medical Asd, Inc.06/01/2018SE
K173110GraftsiteBSP · Traditional Summit Medical , Ltd.05/18/2018SE
K173321StimuQuik 21G x 9cm (3.5”) Peripheral Nerve Block Needle, StimuQuik Echo 21G x 9cm…BSP · Traditional Teleflex Medical04/25/2018SE
K170112IMD's Lumbar Puncture NeedleBSP · Traditional International Medical Development, Inc.(Imd)02/02/2018SE
K171968EchoGlo NeedleBSP · Traditional Smiths Medical Asd, Inc.01/25/2018SE
K171518Epidural Anesthesia Needles, Spinal Anesthesia Needles, Combined Anesthesia NeedlesBSP · Traditional Zhejiang Kindly Medical Devices Co., Ltd.01/05/2018SE
K163292Sonic Block Tuohy, Sonic Block Quincke, Sonic Block Chiba, Sonic Block CrawfordBSP · Traditional Spectra Medical Devices09/08/2017SE
K170435NerveGuard NRFit, NerveGuard LUERBSP · Traditional PAJUNK GmbH Medizintechnologie07/12/2017SE
K163216Pinpoint GT NeedlesBSP · Traditional C.R. Bard, Inc.06/27/2017SE
K163435Entellus Medical Reinforced Anesthesia NeedleBSP · Traditional Entellus Medical, Inc.04/05/2017SE
K160297Tuohy NRFitBSP · Traditional PAJUNK GmbH Medizintechnologie10/28/2016SE
K160296SPROTTE SPECIAL NRFitBSP · Traditional PAJUNK GmbH Medizintechnologie10/27/2016SE
K160295SPROTTE NRFit, Quincke NRFitBSP · Traditional PAJUNK GmbH Medizintechnologie10/27/2016SE
K160294SPROTTE NRFit, Quincke NRFit Lumbar Puncture needlesBSP · Traditional PAJUNK GmbH Medizintechnologie10/21/2016SE
K151069SPECTRA Disposable Single Lumen Echogenic Injection Anesthesia Conduction NeedleBSP · Traditional Spectra Medical Devices, Inc.02/05/2016SE
K151072Solo-Dex Fascile Continuous Peripheral Nerve Block Catheter and Needle KitBSP · Traditional Solo-Dex, Inc.01/22/2016SE
K150266Remington Medical Inc. Tuohy Epidural NeedlesBSP · Traditional Remington Medical, Inc.06/04/2015SE
K142553UNIEVER Disposable Epidural Anesthesia Needle, UNIEVER Disposable Nerve Blocked NeedleBSP · Traditional Unisis Corp.01/14/2015SE
K141126Uniever Disposable Spinal Anesthesia NeedleBSP · Traditional Unisis Corp.10/31/2014SE
K133632Perican UltraBSP · Traditional B.Braun Medical, Inc.06/27/2014SE
K131006Anesthesia Conduction NeedlesBSP · Traditional Lccs Products Limited12/06/2013SE
K121812SonixgpsBSP · Traditional Ultrasonix Medical Corporation12/02/2013SE
K120475Anesthesia Conduction NeedlesBSP · Traditional Shanghai Samedical & Plastic Instruments Co., Ltd.12/21/2012SE
K121846Contiplex C Continuous Peripheral Nerve Block NeedleBSP · Traditional B.Braun Medical, Inc.11/20/2012SE
K113207Sono Tap, Tuohy SonoBSP · Traditional Pajunk GmbH02/29/2012SE
K112515Pencan Spinal NeedleBSP · Traditional B.Braun Medical, Inc.12/22/2011SE
K111374Sono-Series Cornerstone TechniqueBSP · Traditional PAJUNK GmbH Medizintechnologie08/29/2011SE
K110194Medline Epidural and Spinal NeedlesBSP · Traditional Medline Industries, Inc.06/17/2011SE
K101728Focus (TM) Echogenic Nerve Stimulating NeedleBSP · Special Cook, Inc.08/25/2010SE
K100241Contiplex D Continuous Nerve Block Set, Model 331687, 331686, 331685, 331680BSP · Traditional B.Braun Medical, Inc.04/16/2010SE
K093209Focus ( TM) Echogenic Nerve Stimulating NeedleBSP · Traditional Cook, Inc.02/26/2010SE
K091758BD Spinal Needle 27GBSP · Special Becton Dickson & Co.10/09/2009SE
K091818Laurimed Spinal Injection SystemBSP · Special Laurimed, LLC09/23/2009SE
K090261Portex Tuohy Epidural Needle 17G, Portex Tuohy Epidural Needle 18GBSP · Traditional Smiths Medical Asd, Inc.05/01/2009SE
K083909Spinal Injection SystemBSP · Traditional Laurimed, LLC03/18/2009SE
K082772Stimpro, Models SP22050, SP20100, SPP19050, SPP19100, SPP19150, SPC19050, SPC19100…BSP · Traditional Life-Tech, Inc.02/09/2009SE
K081864ProlongBSP · Special Life-Tech, Inc.09/25/2008SE
K080603Hybrid Nerve Location Needle Coated and UncoatedBSP · Traditional Te ME NA Sas08/05/2008SE
K081446BD Spinal Needle, Models: 405081, 405235, 405236, 405237BSP · Abbreviated Becton, Dickinson & CO07/17/2008SE
K080140Laurimed Spinal Injection SystemBSP · Traditional Laurimed, LLC05/09/2008SE
K073222Modification To:Specialty NeedlesBSP · Special Busse Hospital Disposables, Inc.04/09/2008SE
K073516Discyphor Direct Catheter System, Discyphor Direct Needles, Long, Discyphor Direct…BSP · Traditional Kyphon, Inc.02/21/2008SE
K072005RK Epidural NeedleBSP · Traditional Epimed International02/07/2008SE
K063350Dual-Cannula System Acc. Mancao, Special SprotteBSP · Traditional PAJUNK GmbH Medizintechnologie02/01/2008SE
K070354Imd's Anesthesia Needles (Tuohy, Quincke and Pencil Point)BSP · Traditional International Medical Development, Inc.10/05/2007SE
K063380Echostim Facet TipBSP · Traditional Havel'S, Inc.04/25/2007SE
K063071Discyphor Catheter System, Model D01A; Discyphor Introducer Needle, Model D01BBSP · Special Kyphon, Inc.04/13/2007SE
K061394Specialty Needles (Spinal Needle, Pencil Point Spinal Needle, Epidural Needle)BSP · Traditional Busse Hospital Disposables, Inc.09/06/2006SE
K061210Functional Anaesthetic Discography (Fad) Catheter System, Model D01A ; Introducer…BSP · Special Kyphon, Inc.06/27/2006SE
K053318RX Epidural NeedleBSP · Traditional Epimed International, Inc.02/17/2006SE
K050499Probloc, HN Series and Prolong, PL SeriesBSP · Traditional Life-Tech, Inc.05/17/2005SE
K043500Functional Anaesthetic Discography (Fad) System, Including Fad Catheter Kit and Fad…BSP · Traditional Innospine, Inc.04/15/2005SE
K043467Flexible Spinal NeedleBSP · Traditional Epimed International, Inc.03/31/2005SE
K042979Modification to: Plexalong SetsBSP · Special Pajunk GmbH12/21/2004SE
K040965Pajunk Tuohy Needles, Quincke Needles, Chiba Needles & Crawford NeedlesBSP · Traditional Pajunk GmbH09/07/2004SE
K041843Pencil Point NeedleBSP · Traditional Epimed International, Inc.08/24/2004SE
K032981Sppro Esp, Models Esp 603-18-05, Esp 603-18-09BSP · Traditional Invamed Technologies, Inc.04/22/2004SE
K030618Wilson-Cook Celiac Plexus Neurolysis NeedleBSP · Traditional Wilson-Cook Medical, Inc.05/27/2003SE
K030562Tuohy Epidural NeedleBSP · Traditional Epimed International, Inc.04/03/2003SE
K023218Modification to Plexolong SetsBSP · Special Pajunk GmbH03/24/2003SE
K020934Dr. Japan Facil Point Spinal NeedleBSP · Traditional Myco Medical, Inc.10/25/2002SE
K022029Quincke Spinal NeedleBSP · Traditional Epimed International, Inc.07/30/2002SE
K013892Lutz NeedleBSP · Traditional Ballard Medical Products07/11/2002SE
K013610Perifix Safety Epidural NeedlesBSP · Traditional B.Braun Medical, Inc.01/25/2002SE
K013231Avid-Nit Plastic Hub Lutz Epidural Needle,Model RP2035L, Avid-Nit Metal Hub Lutz…BSP · Traditional Avid N.I.T., Inc.12/03/2001SE
K011122Ballpen Spinal Needle W/Wo IntroducerBSP · Traditional Rusch Intl.11/16/2001SE
K011209Manan Spritacre Spinal NeedlesBSP · Traditional Manan Medical Products, Inc.06/26/2001SE
K002405Spinal Epidural NeedlesBSP · Traditional Te ME NA S.A.R.L.06/01/2001SE
K990519Phoenix Epidural & Spinal NeedlesBSP · Traditional Myco Medical Supplies, Inc.06/02/2000SE
K993619Csecure Combined Spinal/Epidural Anesthesia System with LockBSP · Traditional Sims Portex, Inc.04/28/2000SE
K000722Unipolar NeedlesBSP · Traditional Pajunk GmbH03/31/2000SE
K000495Ballard Medical Products Epidural and Spinal NeedlesBSP · Traditional Ballard Medical Products03/28/2000SE
K983620Manan Spinal NeedlesBSP · Traditional Manan Medical Products, Inc.01/08/1999SE
K980536Epidural NeedleBSP · Traditional Manan Medical Products, Inc.07/31/1998SE
K972595Aldrete Epidural Needle Without IntroducerBSP · Traditional Avid N.I.T., Inc.05/20/1998SE
K951928Double-Hole Pencile-Point Spinal Needle (DHPP Spinal Needle)BSP · Traditional Csen , Ltd.05/30/1997SE
K961152Tuohy Epidural NeedlesBSP · Traditional Hakko Shoji Co., Ltd.03/19/1997SE
K961151Spinal NeedlesBSP · Traditional Hakko Shoji Co., Ltd.03/19/1997SE
K962886Anesthesia Conduction NeedleBSP · Traditional Ispg, Inc.10/09/1996SE
K961444Global Medical Combined Spinal Epidural Kit (Gma 1827 and Gma 1725)BSP · Traditional Global Medical Products, Ltd.08/01/1996SE
K940061Polymedic Spinal Needle and IntroducerBSP · Traditional Techniques Medicales DE Navaree12/21/1995SE
K952275Global Medical Products Tuohy & Crawford Epidural Needle W/Plastic HubBSP · Traditional Global Medical Prods, Inc.10/11/1995SE
K951949Clear Hub Spinal Needle, 18, 20, 22, 25 Ga.BSP · Traditional Baxter Healthcare Corp08/11/1995SE
K942863Epidural NeedleBSP · Traditional Spinal Specialties, Inc.08/11/1995SE
K945965Atraumatic Pencil Point Spinal NeedleBSP · Traditional Avid N.I.T., Inc.08/02/1995SE
K946047Holgrath Metal-Hub, Epidural NeedleBSP · Traditional Holgrath Medical Technologies, Inc.07/25/1995SE
K950820Spinal Specialties Pencil-Point Spinal NeedleBSP · Traditional Spinal Specialties, Inc.06/30/1995SE
K944908Holgrath Plastic-Hub, Coical Point Spinal NeedleBSP · Traditional Holgrath Medical Technologies, Inc.06/07/1995SE
K944907Holgrath Plastic-Hub, Quincke Spinal NeedleBSP · Traditional Holgrath Medical Technologies, Inc.06/07/1995SE
K944906Holgrath Plastic-Hub Epidural NeedleBSP · Traditional Holgrath Medical Technologies, Inc.06/07/1995SE
K944905Holgrath Plastic-Hub, Whitacre Style Spinal NeedleBSP · Traditional Holgrath Medical Technologies, Inc.06/07/1995SE
K951312Monoject Whitacre Point Spinal Needle (27G X 3 1/2)BSP · Traditional Sherwood Medical Co.05/03/1995SE
K951411Monoject Tuohy Point Epidural Needle (22G X 3 1/2)BSP · Traditional Sherwood Medical Co.05/01/1995SE
K951265Monoject Diamond Point Spinal Needle (28G X 3 1/2)BSP · Traditional Sherwood Medical Co.04/10/1995SE
K943649Gertie Marx NeedleBSP · Traditional Manan Medical Products, Inc.03/22/1995SE
K935255Eldor NeedleBSP · Traditional Csen , Ltd.02/01/1995SE
K932569Pencil Point Spinal Needle and TrayBSP · Traditional B. Braun of America, Inc.01/26/1994SE
K932400Espocan Combined Spinal/Epidural Needle Set & TrayBSP · Traditional B. Braun of America, Inc.12/13/1993SEKD
K931644Gertie Marx NeedleBSP · Traditional Intl. Medical-Dental Products USA, Inc.09/22/1993SE
K921683Pencil Point Spinal NeedleBSP · Traditional Hart Enterprises, Inc.08/26/1993SE
K925831Mediziv Spinal Needle SetBSP · Traditional Medicia Medical Products07/16/1993SE
K923003Pajunk Standard Sprotte Needle W/ Introducer Cann.BSP · Traditional Rusch, Inc.04/15/1993SE
K921288Curity Calibrated Tuohy Type Epidural NeedleBSP · Traditional Kendall Healthcare Products Co. Div.Of Tyco Health01/27/1993SE
K920305Pharmaseal Clear Hub Spinal NeedleBSP · Traditional Baxter Healthcare Corp01/27/1993SE
K911221Atraumatic Special Sprotte NeedleBSP · Traditional Pajunk GmbH07/24/1992SE
K911202Atraumatic Standard Sprotte NeedleBSP · Traditional Pajunk GmbH05/04/1992SE
K911260Atraumatic Standard Sprotte NeedleBSP · Traditional Pajunk GmbH10/21/1991SE
K910652Spinal Tap NeedleBSP · Traditional Gesco Intl., Inc.07/24/1991SE
K901810Micro-Sp Lumbar Puncture (Spinal) NeedleBSP · Traditional Neuro Technology05/30/1991SE
K901811Add'L Data E-Sp Multipurpose Epidural SpinalneedleBSP · Traditional Neuro Technology05/28/1991SE
K910791Curity(R) Calib Tuohy Type Epidur Needle Fix WingBSP · Traditional Kendall Healthcare Products Co. Div.Of Tyco Health05/17/1991SE
K903224EpisensorBSP · Traditional Palex Intl. SA12/24/1990SE
K894882Infiltration Pump SyringeBSP · Traditional R. J. Doyle, Inc.11/30/1989SE
K89488120GA X 7-1/2 Threading Bullet Point NeedleBSP · Traditional R. J. Doyle, Inc.11/30/1989SE
K89488016GA X 14 Fourteen Long Long Bullet Point NeedlBSP · Traditional R. J. Doyle, Inc.11/30/1989SE
K89487916GA X 10 Middle Size Bullet Point NeedleBSP · Traditional R. J. Doyle, Inc.11/30/1989SE
K89487816GA X 6 Bullet Point Needle, Flex Stainless SteeBSP · Traditional R. J. Doyle, Inc.11/30/1989SE
K895453Spinal NeedleBSP · Traditional Advance Medical Designs, Inc.10/19/1989SE
K853478Pinpoint NeedleBSP · Traditional Regional Master Corp.01/15/1986SE
K854816Epidural Anesthesia NeedlesBSP · Traditional Reganes, Inc.12/19/1985SE
K854149TSK Steriject Sterile Epidural NeedleBSP · Traditional Pharmacia, Inc.10/23/1985SE
K851478Vygon Spinal Anesthesia Needle W/Introducer 183BSP · Traditional Vygon Corp.05/07/1985SE
K850111Aires Tuohy Needles 17GA. X 4 1/2BSP · Traditional Aries Medical, Inc.01/24/1985SE
K843313Top Disposable Spinal NeedleBSP · Traditional Top Surgical Manufacturers Co.09/19/1984SE
K832126Micro Z Dispos. Spinal Anesth. NeedleBSP · Traditional Smith & Nephew, Mpl Division08/12/1983SE
K832233Epineed Epidural NeedleBSP · Traditional Terumo Medical Corp.08/08/1983SE
K823692Spinal NeedleBSP · Traditional Ocean Medical Products, Ltd.01/07/1983SE
K822630Monoject Plastic Hub Spinal NeedleBSP · Traditional Sherwood Medical Co.10/04/1982SE
K820047Spinocan Spinal NeedleBSP · Traditional Burron Medical Products, Inc.01/25/1982SE
K813236Epican Epidural Cannula, Bevel AccordBSP · Traditional Burron Medical Products, Inc.12/03/1981SE
K813179Perican, Epidural CannulaBSP · Traditional Burron Medical Products, Inc.12/03/1981SE
K813165Plexufix Brachial Plexus Anesth. NeedleBSP · Traditional Burron Medical Products, Inc.12/03/1981SE
K811963Visitec Needle Range (Anesthesiology)BSP · Traditional Visitec Co.07/16/1981SE

Recalls

RecallProductFirmInitiated
Z-2389-2026 Class IDescription/REF: SPINAL ANESTHESIA KIT/ASA-24090-SB; SPINAL ANESTHESIA KIT/ASA-24103-SB…Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits… Arrow International, LLC04/21/2026Open, Classified
Z-0152-2022 Class IIsmiths medical portex Loss of Resistance Device, REF 100/398/000The labeling was missing information on sterilization and prohibition of reuse. Smiths Medical ASD Inc.12/08/2020Terminated
Z-1250-2020 Class IIArrow SPINAL ANESTHESIA SET ASA-25090-SProduct lidstock contains the incorrect expiration date for the product Arrow International Inc12/20/2019Terminated
Z-2130-2020 Class IISprotte Needle, REF 33115131B w/ Intro 20 G x 3.5", distributed by Teleflex Medical The…Teleflex received the attached Medical Device Recall Notice from Pajunk Medical. Teleflex Medical is a… Teleflex Medical Inc10/11/2019Open, Classified
Z-2129-2020 Class IISprotte Needle, REF 32115130C w/ Intro 22 G x 3.5", distributed by Teleflex Medical The…Teleflex received the attached Medical Device Recall Notice from Pajunk Medical. Teleflex Medical is a… Teleflex Medical Inc10/11/2019Open, Classified
Z-0234-2020 Class IISPROTTE Lumbar with Introducer, labeled as the following: 1. Sprotte 22G x 90mm w/…Problem with packaging sealing process which affects sterility. Pajunk GmbH08/30/2019Open, Classified
Z-0086-2017 Class II15 g R.K. Epidural Needle (TW), Catalog #/REF #100-1415 Intended for the epidural…There is a possibility that the needles may have the potential to skive a catheters outer coating. If this… Epimed International, Inc.04/22/2016Terminated
Z-2056-2015 Class IIIntegra Long Epidural Steroid Injection Needle (Tuohy Needle), 20 gauge x 5 inch.…Integra LifeSciences Corp. d.b.a. Integra Pain Management Announces Voluntary Recall of Tuohy Needles (20… Integra LifeSciences Corp. d.b.a. Integra…05/01/2015Terminated
Z-1544-2015 Class IIIntegra Long Epidural Steroid Injection Needle (Tuohy Needle), 18 Gauge x 5 inch…A single lot of 18 Gauge, 3.5 inch Tuohy Needles were incorrectly packaged and labeled as 18 Gauge, 5 inch… Integra LifeSciences Corp. d.b.a. Integra…03/30/2015Terminated
Z-1666-2014 Class IISprotte Spinal Tray / Sprotte Spinal Needle 24 gauge with Introducer Spinal injection of…B.Braun Medical, Inc. (BBMI) has received reports of 24 gauge Sprotte Needles that are missing the… B. Braun Medical, Inc.04/03/2014Terminated
Z-1609-2014 Class IIUltrasound USB needles, with 30 degree bevel, packaged individually, 10 needles/box…Ultrasound needles may be defective and leak at the needle hub. RM Temena GmbH03/19/2014Terminated
Z-1608-2014 Class IIUltrasound needles, 22G (0.7 mm) x 50mm, packaged individually, 10 needles/box, item…Ultrasound needles may be defective and leak at the needle hub. RM Temena GmbH03/19/2014Terminated
Z-0949-2008 Kyphon, Functional Anaesthetic Discography (F.A.D.) Introducer Needle, Catalog Number:…Guidewire Breakages: during the Functional Anaesthetic Discography (F.A.D.) procedure. Kyphon Inc04/25/2006Terminated
Z-0948-2008 Functional Anaesthetic Discography (F.A.D.) Catheter System, Catalog #: D01A, Kyphon…Guidewire Breakages: during the Functional Anaesthetic Discography (F.A.D.) procedure. Kyphon Inc04/25/2006Terminated