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
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
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
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
K111374 PAJUNK GMBH MEDIZINTECHNOLOGIE SONO-SERIES CORNERSTONE TECHNIQUE 08/29/2011
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 6/4/2015
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
K090261 SMITHS MEDICAL ASD, INC. PORTEX TUOHY EPIDURAL NEEDLE 17G, PORTEX TUOHY EPIDURAL NEEDLE 18G 05/01/2009
K942863 SPINAL SPECIALTIES, INC. EPIDURAL NEEDLE 08/11/1995
K950820 SPINAL SPECIALTIES, INC. SPINAL SPECIALTIES PENCIL-POINT SPINAL NEEDLE 06/30/1995
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
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 1/14/2015
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


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