FDA 510(k) Applications for Medical Device Product Code "BSP"
(Needle, Conduction, Anesthetic (W/Wo Introducer))
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K191290 | Ancora Medical Technology | Ancora Nerve Block Catheter Set | 02/06/2020 |
| K972595 | AVID N.I.T., INC. | ALDRETE EPIDURAL NEEDLE WITHOUT INTRODUCER | 05/20/1998 |
| K013231 | AVID N.I.T., INC. | AVID-NIT PLASTIC HUB LUTZ EPIDURAL NEEDLE,MODEL RP2035L, AVID-NIT METAL HUB LUTZ EPIDURAL NEEDLE, MODEL RM2035L | 12/03/2001 |
| K121846 | B. BRAUN MEDICAL, INC. | CONTIPLEX C CONTINUOUS PERIPHERAL NERVE BLOCK NEEDLE | 11/20/2012 |
| K100241 | B. BRAUN MEDICAL, INC. | CONTIPLEX D CONTINUOUS NERVE BLOCK SET, MODEL 331687, 331686, 331685, 331680 | 04/16/2010 |
| K112515 | B. BRAUN MEDICAL, INC. | PENCAN SPINAL NEEDLE | 12/22/2011 |
| K013610 | B. BRAUN MEDICAL, INC. | PERIFIX SAFETY EPIDURAL NEEDLES | 01/25/2002 |
| K133632 | B.BRAUN MEDICAL, INC | PERICAN ULTRA | 06/27/2014 |
| K000495 | BALLARD MEDICAL PRODUCTS | BALLARD MEDICAL PRODUCTS EPIDURAL AND SPINAL NEEDLES | 03/28/2000 |
| K013892 | BALLARD MEDICAL PRODUCTS | LUTZ NEEDLE | 07/11/2002 |
| K081446 | BECTON DICKINSON & CO. | BD SPINAL NEEDLE, MODELS: 405081, 405235, 405236, 405237 | 07/17/2008 |
| K091758 | BECTON DICKSON & CO. | BD SPINAL NEEDLE 27G | 10/09/2009 |
| K211085 | Becton, Dickinson and Company | BD Perisafe Tuohy Epidural Needle, BD Perisafe Weiss Epidural Needle | 07/01/2022 |
| K210978 | Becton, Dickinson and Company | BD Quincke Spinal Needle, BD Whitacre Spinal Needle, BD Spinal Introducer Needle | 12/22/2021 |
| K193131 | Becton, Dickinson and Company | BD Quincke Spinal NRFit Needle, BD Whitacre Spinal NRFit Needle, BD Spinal Introducer NRFit Needle | 09/29/2020 |
| K073222 | BUSSE HOSPITAL DISPOSABLES, INC. | MODIFICATION TO:SPECIALTY NEEDLES | 04/09/2008 |
| K061394 | BUSSE HOSPITAL DISPOSABLES, INC. | SPECIALTY NEEDLES (SPINAL NEEDLE, PENCIL POINT SPINAL NEEDLE, EPIDURAL NEEDLE) | 09/06/2006 |
| K163216 | C.R. Bard, Inc. | Pinpoint GT Needles | 06/27/2017 |
| K173155 | Cook Incorporated | Pakter Curved Needle Set | 06/07/2018 |
| K093209 | COOK, INC. | FOCUS ( TM) ECHOGENIC NERVE STIMULATING NEEDLE | 02/26/2010 |
| K101728 | COOK, INC. | FOCUS (TM) ECHOGENIC NERVE STIMULATING NEEDLE | 08/25/2010 |
| K951928 | CSEN LTD. | DOUBLE-HOLE PENCILE-POINT SPINAL NEEDLE (DHPP SPINAL NEEDLE) | 05/30/1997 |
| K212328 | DiscCath LLC | DiscCath Needle Set | 09/26/2021 |
| K183316 | Dr. Japan Co., Ltd. | Dr J Spinal and Epidural Needles | 08/12/2019 |
| K163435 | Entellus Medical Inc. | Entellus Medical Reinforced Anesthesia Needle | 04/05/2017 |
| K072005 | EPIMED INTERNATIONAL | RK EPIDURAL NEEDLE | 02/07/2008 |
| K043467 | EPIMED INTERNATIONAL, INC. | FLEXIBLE SPINAL NEEDLE | 03/31/2005 |
| K041843 | EPIMED INTERNATIONAL, INC. | PENCIL POINT NEEDLE | 08/24/2004 |
| K022029 | EPIMED INTERNATIONAL, INC. | QUINCKE SPINAL NEEDLE | 07/30/2002 |
| K053318 | EPIMED INTERNATIONAL, INC. | RX EPIDURAL NEEDLE | 02/17/2006 |
| K030562 | EPIMED INTERNATIONAL, INC. | TUOHY EPIDURAL NEEDLE | 04/03/2003 |
| K961444 | GLOBAL MEDICAL PRODUCTS, LTD. | GLOBAL MEDICAL COMBINED SPINAL EPIDURAL KIT (GMA 1827 AND GMA 1725) | 08/01/1996 |
| K212982 | Global Medikit Limited | Medispine - Spinal Needle, Glospine - Spinal Needle | 07/29/2022 |
| K961151 | HAKKO SHOJI CO., LTD. | SPINAL NEEDLES | 03/19/1997 |
| K961152 | HAKKO SHOJI CO., LTD. | TUOHY EPIDURAL NEEDLES | 03/19/1997 |
| K063380 | HAVEL'S, INC. | ECHOSTIM FACET TIP | 04/25/2007 |
| K043500 | INNOSPINE, INC. | FUNCTIONAL ANAESTHETIC DISCOGRAPHY (FAD) SYSTEM, INCLUDING FAD CATHETER KIT AND FAD INTRODUCER NEEDLE | 04/15/2005 |
| K070354 | INTERNATIONAL MEDICAL DEVELOPMENT, INC | IMD'S ANESTHESIA NEEDLES (TUOHY, QUINCKE AND PENCIL POINT) | 10/05/2007 |
| K170112 | INTERNATIONAL MEDICAL DEVELOPMENT, INC.(IMD) | IMD's Lumbar Puncture Needle | 02/02/2018 |
| K032981 | INVAMED TECHNOLOGIES INC. | SPPRO ESP, MODELS ESP 603-18-05, ESP 603-18-09 | 04/22/2004 |
| K962886 | ISPG, INC. | ANESTHESIA CONDUCTION NEEDLE | 10/09/1996 |
| K063071 | KYPHON, INC. | DISCYPHOR CATHETER SYSTEM, MODEL D01A; DISCYPHOR INTRODUCER NEEDLE, MODEL D01B | 04/13/2007 |
| K073516 | KYPHON, INC. | DISCYPHOR DIRECT CATHETER SYSTEM, DISCYPHOR DIRECT NEEDLES, LONG, DISCYPHOR DIRECT NEEDLES, REGULAR | 02/21/2008 |
| K061210 | KYPHON, INC. | FUNCTIONAL ANAESTHETIC DISCOGRAPHY (FAD) CATHETER SYSTEM, MODEL D01A ; INTRODUCER NEEDLE, MODEL D01B | 06/27/2006 |
| K080140 | LAURIMED LLC | LAURIMED SPINAL INJECTION SYSTEM | 05/09/2008 |
| K091818 | LAURIMED LLC | LAURIMED SPINAL INJECTION SYSTEM | 09/23/2009 |
| K083909 | LAURIMED LLC | SPINAL INJECTION SYSTEM | 03/18/2009 |
| K131006 | LCCS PRODUCTS LIMITED | ANESTHESIA CONDUCTION NEEDLES | 12/06/2013 |
| K050499 | LIFE-TECH, INC. | PROBLOC, HN SERIES AND PROLONG, PL SERIES | 05/17/2005 |
| K081864 | LIFE-TECH, INC. | PROLONG | 09/25/2008 |
| K082772 | LIFE-TECH, INC. | STIMPRO, MODELS SP22050, SP20100, SPP19050, SPP19100, SPP19150, SPC19050, SPC19100, SPC19150, SPC18050,SPC18100,SPC18150 | 02/09/2009 |
| K980536 | MANAN MEDICAL PRODUCTS, INC. | EPIDURAL NEEDLE | 07/31/1998 |
| K983620 | MANAN MEDICAL PRODUCTS, INC. | MANAN SPINAL NEEDLES | 01/08/1999 |
| K011209 | MANAN MEDICAL PRODUCTS, INC. | MANAN SPRITACRE SPINAL NEEDLES | 06/26/2001 |
| K110194 | MEDLINE, INDUSTRIES, INC. | MEDLINE EPIDURAL AND SPINAL NEEDLES | 06/17/2011 |
| K990519 | MYCO MEDICAL SUPPLIES, INC. | PHOENIX EPIDURAL & SPINAL NEEDLES | 06/02/2000 |
| K203668 | MYCO Medical Supplies, Inc. | RELI NRFit Epidural Needles, Phoenix NRFit Epidural Needles, RELI NRFit Spinal Needles, Phoenix NRFit Spinal Needles | 09/29/2021 |
| K020934 | MYCO MEDICAL, INC. | DR. JAPAN FACIL POINT SPINAL NEEDLE | 10/25/2002 |
| K023218 | PAJUNK GMBH | MODIFICATION TO PLEXOLONG SETS | 03/24/2003 |
| K042979 | PAJUNK GMBH | MODIFICATION TO: PLEXALONG SETS | 12/21/2004 |
| K040965 | PAJUNK GMBH | PAJUNK TUOHY NEEDLES, QUINCKE NEEDLES, CHIBA NEEDLES & CRAWFORD NEEDLES | 09/07/2004 |
| K113207 | PAJUNK GMBH | SONO TAP, TUOHY SONO | 02/29/2012 |
| K000722 | PAJUNK GMBH | UNIPOLAR NEEDLES | 03/31/2000 |
| K063350 | PAJUNK GMBH MEDIZINTECHNOLOGIE | DUAL-CANNULA SYSTEM ACC. MANCAO, SPECIAL SPROTTE | 02/01/2008 |
| K170435 | PAJUNK GmbH Medizintechnologie | NerveGuard NRFit, NerveGuard LUER | 07/12/2017 |
| K111374 | PAJUNK GMBH MEDIZINTECHNOLOGIE | SONO-SERIES CORNERSTONE TECHNIQUE | 08/29/2011 |
| K160295 | PAJUNK GmbH Medizintechnologie | SPROTTE NRFit, Quincke NRFit | 10/27/2016 |
| K160294 | PAJUNK GMBH MEDIZINTECHNOLOGIE | SPROTTE NRFit, Quincke NRFit Lumbar Puncture needles | 10/21/2016 |
| K160296 | PAJUNK GMBH MEDIZINTECHNOLOGIE | SPROTTE SPECIAL NRFit | 10/27/2016 |
| K160297 | PAJUNK GmbH Medizintechnologie | Tuohy NRFit | 10/28/2016 |
| K192914 | Philips Medical Systems Nederland B.V. | Stimuplex Onvision System | 05/27/2020 |
| K150266 | REMINGTON MEDICAL, INC. | Remington Medical Inc. Tuohy Epidural Needles | 06/04/2015 |
| K011122 | RUSCH INTL. | BALLPEN SPINAL NEEDLE W/WO INTRODUCER | 11/16/2001 |
| K120475 | SHANGHAI SA MEDICAL & PLASTIC INSTRUMENTS CO., LTD | ANESTHESIA CONDUCTION NEEDLES | 12/21/2012 |
| K993619 | SIMS PORTEX, INC. | CSECURE COMBINED SPINAL/EPIDURAL ANESTHESIA SYSTEM WITH LOCK | 04/28/2000 |
| K171968 | Smiths Medical ASD, Inc. | EchoGlo Needle | 01/25/2018 |
| K172823 | Smiths Medical ASD, Inc. | Portex NRFit Epidural Needles | 06/12/2018 |
| K172410 | Smiths Medical ASD, Inc. | Portex NRFit Epidural Needles, Portex NRFit Spinal Needles, Portex NRFit Loss of Resistance (L.O.R.) Syringes., Portex EpiFuse Catheter Connector, Portex Regional Anaesthesia Portfolio Filters | 06/01/2018 |
| K090261 | SMITHS MEDICAL ASD, INC. | PORTEX TUOHY EPIDURAL NEEDLE 17G, PORTEX TUOHY EPIDURAL NEEDLE 18G | 05/01/2009 |
| K151072 | Solo-Dex, Inc. | Solo-Dex Fascile Continuous Peripheral Nerve Block Catheter and Needle Kit | 01/22/2016 |
| K163292 | SPECTRA MEDICAL DEVICES | Sonic Block Tuohy, Sonic Block Quincke, Sonic Block Chiba, Sonic Block Crawford | 09/08/2017 |
| K151069 | SPECTRA MEDICAL DEVICES, INC. | SPECTRA Disposable Single Lumen Echogenic Injection Anesthesia Conduction Needle | 02/05/2016 |
| K173110 | Summit Medical Ltd. | GRAFTSITE | 05/18/2018 |
| K002405 | TE ME NA S.A.R.L. | SPINAL EPIDURAL NEEDLES | 06/01/2001 |
| K080603 | TE ME NA SAS | HYBRID NERVE LOCATION NEEDLE COATED AND UNCOATED | 08/05/2008 |
| K190026 | Teleflex Medical | Arrow Epidural Needle KZ-05500-007(Luer); KZ-05500-009 (NRFit) | 08/21/2019 |
| K173321 | Teleflex Medical | StimuQuik 21G x 9cm (3.5ö) Peripheral Nerve Block Needle, StimuQuik Echo 21G x 9cm (3.5ö) Peripheral Nerve Block Needle, StimuQuik 21G x 15cm (6ö) Peripheral Nerve Block Needle, StimuQuik Echo 21G x 15cm (6ö) Peripheral Nerve Block Needle, StimuQuik 21G x | 04/25/2018 |
| K121812 | UltraSonix Medical Corporation | SONIXGPS | 12/02/2013 |
| K142553 | UNISIS CORP. | UNIEVER Disposable Epidural Anesthesia Needle, UNIEVER Disposable Nerve Blocked Needle | 01/14/2015 |
| K141126 | UNISIS CORP. | UNIEVER DISPOSABLE SPINAL ANESTHESIA NEEDLE | 10/31/2014 |
| K030618 | WILSON-COOK MEDICAL, INC. | WILSON-COOK CELIAC PLEXUS NEUROLYSIS NEEDLE | 05/27/2003 |
| K171518 | Zhejiang kindly Medical Devices Co., Ltd | Epidural Anesthesia Needles, Spinal Anesthesia Needles, Combined Anesthesia Needles | 01/05/2018 |
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