Product Code: BSP FDA class 2 21 CFR 868.5150

Needle, Conduction, Anesthetic (W/Wo Introducer)

Anesthesiology

The Needle, Conduction, Anesthetic (W/Wo Introducer) is a needle used to inject local anesthetic agents near nerves or into specific anatomical spaces to achieve regional anesthesia, optionally supplied with an introducer to guide placement. It is classified as FDA Class 2, requiring 510(k) premarket notification. The product code is BSP, regulated under 21 CFR 868.5150 in the Anesthesiology specialty. This device is eligible for third-party 510(k) review.

510(k)s
152
FEI Numbers
136
Registration Numbers
136
Unique Applicants
82
Years Active
44

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Basic Information

Product Code
BSP
Device Class
FDA class 2
Regulation Number
868.5150
Medical Specialty
Anesthesiology
Review Panel
AN
Submission Type
1

Device Characteristics

GMP Exempt
Implant
Life Sustain/Support
Third Party
Summary Malfunction Reporting

510(k) Clearance History

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Related 510(k) Clearances

This FDA classification is associated with 152 510(k) clearances via K numbers.

K Number Device Name
K243690 SonoMSK
K243682 SonoPlex STIM; SonoPlex II
K250774 SPROTTE® STANDARD (LUER/ NRFit®) Lumbar Puncture
K243525 SonoTAP and SonoTAP II
K241953 SPROTTE® STANDARD (LUER/ NRFit®) Anesthesiology
K241954 SonoBlock; SonoBlock II
K240253 Reach Needle
K212982 Medispine - Spinal Needle, Glospine - Spinal Needle
K211085 BD Perisafe Tuohy Epidural Needle, BD Perisafe Weiss Epidural Needle
K210978 BD Quincke Spinal Needle, BD Whitacre Spinal Needle, BD Spinal Introducer Needle
K203668 RELI NRFit Epidural Needles, Phoenix NRFit Epidural Needles, RELI NRFit Spinal Needles, Phoenix NRFit Spinal Needles
K212328 DiscCath Needle Set
K193131 BD Quincke Spinal NRFit Needle, BD Whitacre Spinal NRFit Needle, BD Spinal Introducer NRFit Needle
K192914 Stimuplex Onvision System
K191290 Ancora Nerve Block Catheter Set
K190026 Arrow Epidural Needle KZ-05500-007(Luer); KZ-05500-009 (NRFit)
K183316 Dr J Spinal and Epidural Needles
K172823 Portex NRFit Epidural Needles
K173155 Pakter Curved Needle Set
K172410 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
K173110 GRAFTSITE
K173321 StimuQuik 21G x 9cm (3.5”) Peripheral Nerve Block Needle, StimuQuik Echo 21G x 9cm (3.5”) Peripheral Nerve Block Needle, StimuQuik 21G x 15cm (6”) Peripheral Nerve Block Needle, StimuQuik Echo 21G x 15cm (6”) Peripheral Nerve Block Needle, StimuQuik 21G x 2.5cm (1”) Peripheral Nerve Block Needle
K170112 IMD's Lumbar Puncture Needle
K171968 EchoGlo Needle
K171518 Epidural Anesthesia Needles, Spinal Anesthesia Needles, Combined Anesthesia Needles
K163292 Sonic Block Tuohy, Sonic Block Quincke, Sonic Block Chiba, Sonic Block Crawford
K170435 NerveGuard NRFit, NerveGuard LUER
K163216 Pinpoint GT Needles
K163435 Entellus Medical Reinforced Anesthesia Needle
K160297 Tuohy NRFit
K160296 SPROTTE SPECIAL NRFit
K160295 SPROTTE NRFit, Quincke NRFit
K160294 SPROTTE NRFit, Quincke NRFit Lumbar Puncture needles
K151069 SPECTRA Disposable Single Lumen Echogenic Injection Anesthesia Conduction Needle
K151072 Solo-Dex Fascile Continuous Peripheral Nerve Block Catheter and Needle Kit
K150266 Remington Medical Inc. Tuohy Epidural Needles
K142553 UNIEVER Disposable Epidural Anesthesia Needle, UNIEVER Disposable Nerve Blocked Needle
K141126 UNIEVER DISPOSABLE SPINAL ANESTHESIA NEEDLE
K133632 PERICAN ULTRA
K131006 ANESTHESIA CONDUCTION NEEDLES
K121812 SONIXGPS
K120475 ANESTHESIA CONDUCTION NEEDLES
K121846 CONTIPLEX C CONTINUOUS PERIPHERAL NERVE BLOCK NEEDLE
K113207 SONO TAP, TUOHY SONO
K112515 PENCAN SPINAL NEEDLE
K111374 SONO-SERIES CORNERSTONE TECHNIQUE
K110194 MEDLINE EPIDURAL AND SPINAL NEEDLES
K101728 FOCUS (TM) ECHOGENIC NERVE STIMULATING NEEDLE
K100241 CONTIPLEX D CONTINUOUS NERVE BLOCK SET, MODEL 331687, 331686, 331685, 331680
K093209 FOCUS ( TM) ECHOGENIC NERVE STIMULATING NEEDLE
K091758 BD SPINAL NEEDLE 27G
K091818 LAURIMED SPINAL INJECTION SYSTEM
K090261 PORTEX TUOHY EPIDURAL NEEDLE 17G, PORTEX TUOHY EPIDURAL NEEDLE 18G
K083909 SPINAL INJECTION SYSTEM
K082772 STIMPRO, MODELS SP22050, SP20100, SPP19050, SPP19100, SPP19150, SPC19050, SPC19100, SPC19150, SPC18050,SPC18100,SPC18150
K081864 PROLONG
K080603 HYBRID NERVE LOCATION NEEDLE COATED AND UNCOATED
K081446 BD SPINAL NEEDLE, MODELS: 405081, 405235, 405236, 405237
K080140 LAURIMED SPINAL INJECTION SYSTEM
K073222 MODIFICATION TO:SPECIALTY NEEDLES
K073516 DISCYPHOR DIRECT CATHETER SYSTEM, DISCYPHOR DIRECT NEEDLES, LONG, DISCYPHOR DIRECT NEEDLES, REGULAR
K072005 RK EPIDURAL NEEDLE
K063350 DUAL-CANNULA SYSTEM ACC. MANCAO, SPECIAL SPROTTE
K070354 IMD'S ANESTHESIA NEEDLES (TUOHY, QUINCKE AND PENCIL POINT)
K063380 ECHOSTIM FACET TIP
K063071 DISCYPHOR CATHETER SYSTEM, MODEL D01A; DISCYPHOR INTRODUCER NEEDLE, MODEL D01B
K061394 SPECIALTY NEEDLES (SPINAL NEEDLE, PENCIL POINT SPINAL NEEDLE, EPIDURAL NEEDLE)
K061210 FUNCTIONAL ANAESTHETIC DISCOGRAPHY (FAD) CATHETER SYSTEM, MODEL D01A ; INTRODUCER NEEDLE, MODEL D01B
K053318 RX EPIDURAL NEEDLE
K050499 PROBLOC, HN SERIES AND PROLONG, PL SERIES
K043500 FUNCTIONAL ANAESTHETIC DISCOGRAPHY (FAD) SYSTEM, INCLUDING FAD CATHETER KIT AND FAD INTRODUCER NEEDLE
K043467 FLEXIBLE SPINAL NEEDLE
K042979 MODIFICATION TO: PLEXALONG SETS
K040965 PAJUNK TUOHY NEEDLES, QUINCKE NEEDLES, CHIBA NEEDLES & CRAWFORD NEEDLES
K041843 PENCIL POINT NEEDLE
K032981 SPPRO ESP, MODELS ESP 603-18-05, ESP 603-18-09
K030618 WILSON-COOK CELIAC PLEXUS NEUROLYSIS NEEDLE
K030562 TUOHY EPIDURAL NEEDLE
K023218 MODIFICATION TO PLEXOLONG SETS
K020934 DR. JAPAN FACIL POINT SPINAL NEEDLE
K022029 QUINCKE SPINAL NEEDLE
K013892 LUTZ NEEDLE
K013610 PERIFIX SAFETY EPIDURAL NEEDLES
K013231 AVID-NIT PLASTIC HUB LUTZ EPIDURAL NEEDLE,MODEL RP2035L, AVID-NIT METAL HUB LUTZ EPIDURAL NEEDLE, MODEL RM2035L
K011122 BALLPEN SPINAL NEEDLE W/WO INTRODUCER
K011209 MANAN SPRITACRE SPINAL NEEDLES
K002405 SPINAL EPIDURAL NEEDLES
K990519 PHOENIX EPIDURAL & SPINAL NEEDLES
K993619 CSECURE COMBINED SPINAL/EPIDURAL ANESTHESIA SYSTEM WITH LOCK
K000722 UNIPOLAR NEEDLES
K000495 BALLARD MEDICAL PRODUCTS EPIDURAL AND SPINAL NEEDLES
K983620 MANAN SPINAL NEEDLES
K980536 EPIDURAL NEEDLE
K972595 ALDRETE EPIDURAL NEEDLE WITHOUT INTRODUCER
K951928 DOUBLE-HOLE PENCILE-POINT SPINAL NEEDLE (DHPP SPINAL NEEDLE)
K961152 TUOHY EPIDURAL NEEDLES
K961151 SPINAL NEEDLES
K962886 ANESTHESIA CONDUCTION NEEDLE
K961444 GLOBAL MEDICAL COMBINED SPINAL EPIDURAL KIT (GMA 1827 AND GMA 1725)
K940061 POLYMEDIC SPINAL NEEDLE AND INTRODUCER
K952275 GLOBAL MEDICAL PRODUCTS TUOHY & CRAWFORD EPIDURAL NEEDLE W/PLASTIC HUB
K951949 CLEAR HUB SPINAL NEEDLE, 18, 20, 22, 25 GA.
K942863 EPIDURAL NEEDLE
K945965 ATRAUMATIC PENCIL POINT SPINAL NEEDLE
K946047 HOLGRATH METAL-HUB, EPIDURAL NEEDLE
K950820 SPINAL SPECIALTIES PENCIL-POINT SPINAL NEEDLE
K944908 HOLGRATH PLASTIC-HUB, COICAL POINT SPINAL NEEDLE
K944907 HOLGRATH PLASTIC-HUB, QUINCKE SPINAL NEEDLE
K944906 HOLGRATH PLASTIC-HUB EPIDURAL NEEDLE
K944905 HOLGRATH PLASTIC-HUB, WHITACRE STYLE SPINAL NEEDLE
K951312 MONOJECT WHITACRE POINT SPINAL NEEDLE (27G X 3 1/2)
K951411 MONOJECT TUOHY POINT EPIDURAL NEEDLE (22G X 3 1/2)
K951265 MONOJECT DIAMOND POINT SPINAL NEEDLE (28G X 3 1/2)
K943649 GERTIE MARX NEEDLE
K935255 ELDOR NEEDLE
K932569 PENCIL POINT SPINAL NEEDLE AND TRAY
K932400 ESPOCAN COMBINED SPINAL/EPIDURAL NEEDLE SET & TRAY
K931644 GERTIE MARX NEEDLE
K921683 PENCIL POINT SPINAL NEEDLE
K925831 MEDIZIV SPINAL NEEDLE SET
K923003 PAJUNK STANDARD SPROTTE NEEDLE W/ INTRODUCER CANN.
K921288 CURITY CALIBRATED TUOHY TYPE EPIDURAL NEEDLE
K920305 PHARMASEAL CLEAR HUB SPINAL NEEDLE
K911221 ATRAUMATIC SPECIAL SPROTTE NEEDLE
K911202 ATRAUMATIC STANDARD SPROTTE NEEDLE
K911260 ATRAUMATIC STANDARD SPROTTE NEEDLE
K910652 SPINAL TAP NEEDLE
K901810 MICRO-SP LUMBAR PUNCTURE (SPINAL) NEEDLE
K901811 ADD'L DATA E-SP MULTIPURPOSE EPIDURAL SPINALNEEDLE
K910791 CURITY(R) CALIB TUOHY TYPE EPIDUR NEEDLE FIX WING
K903224 EPISENSOR
K894882 INFILTRATION PUMP SYRINGE
K894881 20GA X 7-1/2 THREADING BULLET POINT NEEDLE
K894880 16GA X 14 FOURTEEN LONG LONG BULLET POINT NEEDL
K894879 16GA X 10 MIDDLE SIZE BULLET POINT NEEDLE
K894878 16GA X 6 BULLET POINT NEEDLE, FLEX STAINLESS STEE
K895453 SPINAL NEEDLE
K853478 PINPOINT NEEDLE
K854816 EPIDURAL ANESTHESIA NEEDLES
K854149 TSK STERIJECT STERILE EPIDURAL NEEDLE
K851478 VYGON SPINAL ANESTHESIA NEEDLE W/INTRODUCER 183
K850111 AIRES TUOHY NEEDLES 17GA. X 4 1/2
K843313 TOP DISPOSABLE SPINAL NEEDLE
K832126 MICRO Z DISPOS. SPINAL ANESTH. NEEDLE
K832233 EPINEED EPIDURAL NEEDLE
K823692 SPINAL NEEDLE
K822630 MONOJECT PLASTIC HUB SPINAL NEEDLE
K820047 SPINOCAN SPINAL NEEDLE
K813236 EPICAN EPIDURAL CANNULA, BEVEL ACCORD
K813179 PERICAN, EPIDURAL CANNULA
K813165 PLEXUFIX BRACHIAL PLEXUS ANESTH. NEEDLE
K811963 VISITEC NEEDLE RANGE (ANESTHESIOLOGY)

FEI Numbers

This FDA classification entry is associated with 136 FEI numbers. Click on an entry to view related FDA registrations.

Registration Numbers

This FDA classification entry is associated with 136 registration numbers. Click on an entry to view related FDA registrations.