ClearanceBrief
Panels › Anesthesiology › Product code BSP · Class 2

Needle, Conduction, Anesthetic (W/Wo Introducer)

Regulation 868.5150

0510(k)s in 12 months (152 all time)
1recalls in 12 months (17 all time)
15recalls that name a 510(k)
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Top companies in BSP

Company510(k)sRecalls
PAJUNK GmbH Medizintechnologie130
Pajunk GmbH81
B.Braun Medical, Inc.53
Epimed International61
Holgrath Medical Technologies, Inc.50
Kyphon, Inc.32
R. J. Doyle, Inc.50
Smiths Medical Asd, Inc.41
Burron Medical Products, Inc.40
Manan Medical Products, Inc.40
Decided510(k)Device and applicantCode
Jul 1, 2025K243690SonoMSK
PAJUNK GmbH Medizintechnologie, DE
BSP
Jun 27, 2025K243682SonoPlex STIM; SonoPlex II
PAJUNK GmbH Medizintechnologie, DE
BSP
Jun 25, 2025K250774SPROTTE® STANDARD (LUER/ NRFit®) Lumbar Puncture
PAJUNK GmbH Medizintechnologie, DE
BSP
Mar 24, 2025K243525SonoTAP and SonoTAP II
PAJUNK GmbH Medizintechnologie, DE
BSP
Nov 22, 2024K241953SPROTTE® STANDARD (LUER/ NRFit®) Anesthesiology
PAJUNK GmbH Medizintechnologie, DE
BSP
Sep 11, 2024K241954SonoBlock; SonoBlock II
PAJUNK GmbH Medizintechnologie, DE
BSP
Mar 21, 2024K240253Reach Needle
Aerin Medical, Inc.
BSP
Jul 29, 2022K212982Medispine - Spinal Needle, Glospine - Spinal Needle
Global Medikit Limited, IN
BSP
Jul 1, 2022K211085BD Perisafe Tuohy Epidural Needle, BD Perisafe Weiss Epidural Needle
Becton, Dickinson and Company
BSP
Dec 22, 2021K210978BD Quincke Spinal Needle, BD Whitacre Spinal Needle, BD Spinal Introducer Needle
Becton, Dickinson and Company
BSP
Sep 29, 2021K203668RELI NRFit Epidural Needles, Phoenix NRFit Epidural Needles, RELI NRFit Spinal Needles, Phoenix NRFit Spinal Needles
Myco Medical Supplies, Inc.
BSP
Sep 26, 2021K212328DiscCath Needle Set
Disccath, LLC
BSP
Sep 29, 2020K193131BD Quincke Spinal NRFit Needle, BD Whitacre Spinal NRFit Needle, BD Spinal Introducer NRFit Needle
Becton, Dickinson and Company
BSP
May 27, 2020K192914Stimuplex Onvision System
Philips Medical Systems Nederland B.V., NL
BSP
Feb 6, 2020K191290Ancora Nerve Block Catheter Set
Ancora Medical Technology
BSP
Aug 21, 2019K190026Arrow Epidural Needle KZ-05500-007(Luer); KZ-05500-009 (NRFit)
Teleflex Medical
BSP
Aug 12, 2019K183316Dr J Spinal and Epidural Needles
Dr. Japan Co., Ltd., JP
BSP
Jun 12, 2018K172823Portex NRFit Epidural Needles
Smiths Medical Asd, Inc.
BSP
Jun 7, 2018K173155Pakter Curved Needle Set
Cook Incorporated
BSP
Jun 1, 2018K172410Portex NRFit Epidural Needles, Portex NRFit Spinal Needles, Portex NRFit Loss of Resistance (L.O.R.) Syringes., Portex E
Smiths Medical Asd, Inc.
BSP
May 18, 2018K173110GRAFTSITE
Summit Medical , Ltd., GB
BSP
Apr 25, 2018K173321StimuQuik 21G x 9cm (3.5”) Peripheral Nerve Block Needle, StimuQuik Echo 21G x 9cm (3.5”) Peripheral Nerve Block Needle,
Teleflex Medical
BSP
Feb 2, 2018K170112IMD's Lumbar Puncture Needle
International Medical Development, Inc.(Imd)
BSP
Jan 25, 2018K171968EchoGlo Needle
Smiths Medical Asd, Inc.
BSP
Jan 5, 2018K171518Epidural Anesthesia Needles, Spinal Anesthesia Needles, Combined Anesthesia Needles
Zhejiang Kindly Medical Devices Co., Ltd., CN
BSP
Sep 8, 2017K163292Sonic Block Tuohy, Sonic Block Quincke, Sonic Block Chiba, Sonic Block Crawford
Spectra Medical Devices
BSP
Jul 12, 2017K170435NerveGuard NRFit, NerveGuard LUER
PAJUNK GmbH Medizintechnologie, DE
BSP
Jun 27, 2017K163216Pinpoint GT Needles
C.R. Bard, Inc.
BSP
Apr 5, 2017K163435Entellus Medical Reinforced Anesthesia Needle
Entellus Medical, Inc.
BSP
Oct 28, 2016K160297Tuohy NRFit
PAJUNK GmbH Medizintechnologie, DE
BSP
Oct 27, 2016K160296SPROTTE SPECIAL NRFit
PAJUNK GmbH Medizintechnologie, DE
BSP
Oct 27, 2016K160295SPROTTE NRFit, Quincke NRFit
PAJUNK GmbH Medizintechnologie, DE
BSP
Oct 21, 2016K160294SPROTTE NRFit, Quincke NRFit Lumbar Puncture needles
PAJUNK GmbH Medizintechnologie, DE
BSP
Feb 5, 2016K151069SPECTRA Disposable Single Lumen Echogenic Injection Anesthesia Conduction Needle
Spectra Medical Devices, Inc.
BSP
Jan 22, 2016K151072Solo-Dex Fascile Continuous Peripheral Nerve Block Catheter and Needle Kit
Solo-Dex, Inc.
BSP
Jun 4, 2015K150266Remington Medical Inc. Tuohy Epidural Needles
Remington Medical, Inc.
BSP
Jan 14, 2015K142553UNIEVER Disposable Epidural Anesthesia Needle, UNIEVER Disposable Nerve Blocked Needle
Unisis Corp., JP
BSP
Oct 31, 2014K141126UNIEVER DISPOSABLE SPINAL ANESTHESIA NEEDLE
Unisis Corp.
BSP
Jun 27, 2014K133632PERICAN ULTRA
B.Braun Medical, Inc.
BSP
Dec 6, 2013K131006ANESTHESIA CONDUCTION NEEDLES
Lccs Products Limited, CN
BSP
Dec 2, 2013K121812SONIXGPS
Ultrasonix Medical Corporation
BSP
Dec 21, 2012K120475ANESTHESIA CONDUCTION NEEDLES
Shanghai Samedical & Plastic Instruments Co., Ltd., CN
BSP
Nov 20, 2012K121846CONTIPLEX C CONTINUOUS PERIPHERAL NERVE BLOCK NEEDLE
B.Braun Medical, Inc.
BSP
Feb 29, 2012K113207SONO TAP, TUOHY SONO
Pajunk GmbH, DE
BSP
Dec 22, 2011K112515PENCAN SPINAL NEEDLE
B.Braun Medical, Inc.
BSP
Aug 29, 2011K111374SONO-SERIES CORNERSTONE TECHNIQUE
PAJUNK GmbH Medizintechnologie, DE
BSP
Jun 17, 2011K110194MEDLINE EPIDURAL AND SPINAL NEEDLES
Medline Industries, Inc.
BSP
Aug 25, 2010K101728FOCUS (TM) ECHOGENIC NERVE STIMULATING NEEDLE
Cook, Inc.
BSP
Apr 16, 2010K100241CONTIPLEX D CONTINUOUS NERVE BLOCK SET, MODEL 331687, 331686, 331685, 331680
B.Braun Medical, Inc.
BSP
Feb 26, 2010K093209FOCUS ( TM) ECHOGENIC NERVE STIMULATING NEEDLE
Cook, Inc.
BSP

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