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
K895453 ADVANCE MEDICAL DESIGNS, INC. SPINAL NEEDLE 10/19/1989
K850111 ARIES MEDICAL, INC. AIRES TUOHY NEEDLES 17GA. X 4 1/2 01/24/1985
K972595 AVID N.I.T., INC. ALDRETE EPIDURAL NEEDLE WITHOUT INTRODUCER 05/20/1998
K945965 AVID N.I.T., INC. ATRAUMATIC PENCIL POINT SPINAL NEEDLE 08/02/1995
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
K932400 B. BRAUN OF AMERICA, INC. ESPOCAN COMBINED SPINAL/EPIDURAL NEEDLE SET & TRAY 12/13/1993
K932569 B. BRAUN OF AMERICA, INC. PENCIL POINT SPINAL NEEDLE AND TRAY 01/26/1994
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
K951949 BAXTER HEALTHCARE CORP. CLEAR HUB SPINAL NEEDLE, 18, 20, 22, 25 GA. 08/11/1995
K920305 BAXTER HEALTHCARE CORP. PHARMASEAL CLEAR HUB SPINAL NEEDLE 01/27/1993
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
K813236 BURRON MEDICAL PRODUCTS, INC. EPICAN EPIDURAL CANNULA, BEVEL ACCORD 12/03/1981
K813179 BURRON MEDICAL PRODUCTS, INC. PERICAN, EPIDURAL CANNULA 12/03/1981
K813165 BURRON MEDICAL PRODUCTS, INC. PLEXUFIX BRACHIAL PLEXUS ANESTH. NEEDLE 12/03/1981
K820047 BURRON MEDICAL PRODUCTS, INC. SPINOCAN SPINAL NEEDLE 01/25/1982
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
K935255 CSEN LTD. ELDOR NEEDLE 02/01/1995
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
K910652 GESCO INTL., INC. SPINAL TAP NEEDLE 07/24/1991
K952275 GLOBAL MEDICAL PRODS, INC. GLOBAL MEDICAL PRODUCTS TUOHY & CRAWFORD EPIDURAL NEEDLE W/PLASTIC HUB 10/11/1995
K961444 GLOBAL MEDICAL PRODUCTS, LTD. GLOBAL MEDICAL COMBINED SPINAL EPIDURAL KIT (GMA 1827 AND GMA 1725) 08/01/1996
K961151 HAKKO SHOJI CO., LTD. SPINAL NEEDLES 03/19/1997
K961152 HAKKO SHOJI CO., LTD. TUOHY EPIDURAL NEEDLES 03/19/1997
K921683 HART ENTERPRISES, INC. PENCIL POINT SPINAL NEEDLE 08/26/1993
K063380 HAVEL'S, INC. ECHOSTIM FACET TIP 04/25/2007
K946047 HOLGRATH MEDICAL TECHNOLOGIES, INC. HOLGRATH METAL-HUB, EPIDURAL NEEDLE 07/25/1995
K944906 HOLGRATH MEDICAL TECHNOLOGIES, INC. HOLGRATH PLASTIC-HUB EPIDURAL NEEDLE 06/07/1995
K944908 HOLGRATH MEDICAL TECHNOLOGIES, INC. HOLGRATH PLASTIC-HUB, COICAL POINT SPINAL NEEDLE 06/07/1995
K944907 HOLGRATH MEDICAL TECHNOLOGIES, INC. HOLGRATH PLASTIC-HUB, QUINCKE SPINAL NEEDLE 06/07/1995
K944905 HOLGRATH MEDICAL TECHNOLOGIES, INC. HOLGRATH PLASTIC-HUB, WHITACRE STYLE SPINAL NEEDLE 06/07/1995
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
K931644 INTL. MEDICAL-DENTAL PRODUCTS USA, INC. GERTIE MARX NEEDLE 09/22/1993
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
K921288 KENDALL HEALTHCARE PRODUCTS CO. DIV.OF TYCO HEALTH CURITY CALIBRATED TUOHY TYPE EPIDURAL NEEDLE 01/27/1993
K910791 KENDALL HEALTHCARE PRODUCTS CO. DIV.OF TYCO HEALTH CURITY(R) CALIB TUOHY TYPE EPIDUR NEEDLE FIX WING 05/17/1991
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
K943649 MANAN MEDICAL PRODUCTS, INC. GERTIE MARX NEEDLE 03/22/1995
K983620 MANAN MEDICAL PRODUCTS, INC. MANAN SPINAL NEEDLES 01/08/1999
K011209 MANAN MEDICAL PRODUCTS, INC. MANAN SPRITACRE SPINAL NEEDLES 06/26/2001
K925831 MEDICIA MEDICAL PRODUCTS MEDIZIV SPINAL NEEDLE SET 07/16/1993
K110194 MEDLINE, INDUSTRIES, INC. MEDLINE EPIDURAL AND SPINAL NEEDLES 06/17/2011
K990519 MYCO MEDICAL SUPPLIES, INC. PHOENIX EPIDURAL & SPINAL NEEDLES 06/02/2000
K020934 MYCO MEDICAL, INC. DR. JAPAN FACIL POINT SPINAL NEEDLE 10/25/2002
K901811 NEURO TECHNOLOGY ADD'L DATA E-SP MULTIPURPOSE EPIDURAL SPINALNEEDLE 05/28/1991
K901810 NEURO TECHNOLOGY MICRO-SP LUMBAR PUNCTURE (SPINAL) NEEDLE 05/30/1991
K823692 OCEAN MEDICAL PRODUCTS, LTD. SPINAL NEEDLE 01/07/1983
K911221 PAJUNK GMBH ATRAUMATIC SPECIAL SPROTTE NEEDLE 07/24/1992
K911202 PAJUNK GMBH ATRAUMATIC STANDARD SPROTTE NEEDLE 05/04/1992
K911260 PAJUNK GMBH ATRAUMATIC STANDARD SPROTTE NEEDLE 10/21/1991
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
K903224 PALEX INTL. SA EPISENSOR 12/24/1990
K854149 PHARMACIA, INC. TSK STERIJECT STERILE EPIDURAL NEEDLE 10/23/1985
K894879 R. J. DOYLE, INC. 16GA X 10" MIDDLE SIZE BULLET POINT NEEDLE 11/30/1989
K894880 R. J. DOYLE, INC. 16GA X 14" "FOURTEEN LONG" LONG BULLET POINT NEEDL 11/30/1989
K894878 R. J. DOYLE, INC. 16GA X 6" BULLET POINT NEEDLE, FLEX STAINLESS STEE 11/30/1989
K894881 R. J. DOYLE, INC. 20GA X 7-1/2" THREADING BULLET POINT NEEDLE 11/30/1989
K894882 R. J. DOYLE, INC. INFILTRATION PUMP SYRINGE 11/30/1989
K854816 REGANES, INC. EPIDURAL ANESTHESIA NEEDLES 12/19/1985
K853478 REGIONAL MASTER CORP. PINPOINT NEEDLE 01/15/1986
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
K923003 RUSCH, INC. PAJUNK STANDARD SPROTTE NEEDLE W/ INTRODUCER CANN. 04/15/1993
K120475 SHANGHAI SA MEDICAL & PLASTIC INSTRUMENTS CO., LTD ANESTHESIA CONDUCTION NEEDLES 12/21/2012
K951265 SHERWOOD MEDICAL CO. MONOJECT DIAMOND POINT SPINAL NEEDLE (28G X 3 1/2") 04/10/1995
K822630 SHERWOOD MEDICAL CO. MONOJECT PLASTIC HUB SPINAL NEEDLE 10/04/1982
K951411 SHERWOOD MEDICAL CO. MONOJECT TUOHY POINT EPIDURAL NEEDLE (22G X 3 1/2") 05/01/1995
K951312 SHERWOOD MEDICAL CO. MONOJECT WHITACRE POINT SPINAL NEEDLE (27G X 3 1/2") 05/03/1995
K993619 SIMS PORTEX, INC. CSECURE COMBINED SPINAL/EPIDURAL ANESTHESIA SYSTEM WITH LOCK 04/28/2000
K832126 SMITH & NEPHEW, MPL DIVISION MICRO Z DISPOS. SPINAL ANESTH. NEEDLE 08/12/1983
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
K942863 SPINAL SPECIALTIES, INC. EPIDURAL NEEDLE 08/11/1995
K950820 SPINAL SPECIALTIES, INC. SPINAL SPECIALTIES PENCIL-POINT SPINAL NEEDLE 06/30/1995
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
K940061 TECHNIQUES MEDICALES DE NAVAREE POLYMEDIC SPINAL NEEDLE AND INTRODUCER 12/21/1995
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
K832233 TERUMO MEDICAL CORP. EPINEED EPIDURAL NEEDLE 08/08/1983
K843313 TOP SURGICAL MANUFACTURERS CO. TOP DISPOSABLE SPINAL NEEDLE 09/19/1984
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
K811963 VISITEC CO. VISITEC NEEDLE RANGE (ANESTHESIOLOGY) 07/16/1981
K851478 VYGON CORP. VYGON SPINAL ANESTHESIA NEEDLE W/INTRODUCER 183 05/07/1985
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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