BSP — Needle, Conduction, Anesthetic (W/Wo Introducer) Class II

FDA Device Classification

Classification Details

Product Code
BSP
Device Class
Class II
Regulation Number
868.5150
Submission Type
Review Panel
AN
Medical Specialty
Anesthesiology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K243690pajunk gmbh medizintechnologieSonoMSKJuly 1, 2025
K243682pajunk gmbh medizintechnologieSonoPlex STIM; SonoPlex IIJune 27, 2025
K250774pajunk gmbh medizintechnologieSPROTTE® STANDARD (LUER/ NRFit®) Lumbar PunctureJune 25, 2025
K243525pajunk gmbh medizintechnologieSonoTAP and SonoTAP IIMarch 24, 2025
K241953pajunk gmbh medizintechnologieSPROTTE® STANDARD (LUER/ NRFit®) AnesthesiologyNovember 22, 2024
K241954pajunk gmbh medizintechnologieSonoBlock; SonoBlock IISeptember 11, 2024
K240253aerin medicalReach NeedleMarch 21, 2024
K212982global medikit limitedMedispine - Spinal Needle, Glospine - Spinal NeedleJuly 29, 2022
K211085becton, dickinson andBD Perisafe Tuohy Epidural Needle, BD Perisafe Weiss Epidural NeedleJuly 1, 2022
K210978becton, dickinson andBD Quincke Spinal Needle, BD Whitacre Spinal Needle, BD Spinal Introducer NeedleDecember 22, 2021
K203668myco medical suppliesRELI NRFit Epidural Needles, Phoenix NRFit Epidural Needles, RELI NRFit Spinal NSeptember 29, 2021
K212328disccathDiscCath Needle SetSeptember 26, 2021
K193131becton, dickinson andBD Quincke Spinal NRFit Needle, BD Whitacre Spinal NRFit Needle, BD Spinal IntroSeptember 29, 2020
K192914philips medical systems nederlandStimuplex Onvision SystemMay 27, 2020
K191290ancora medical technologyAncora Nerve Block Catheter SetFebruary 6, 2020
K190026teleflex medicalArrow Epidural Needle KZ-05500-007(Luer); KZ-05500-009 (NRFit)August 21, 2019
K183316japan coDr J Spinal and Epidural NeedlesAugust 12, 2019
K172823smiths medical asdPortex NRFit Epidural NeedlesJune 12, 2018
K173155cook incorporatedPakter Curved Needle SetJune 7, 2018
K172410smiths medical asdPortex NRFit Epidural Needles, Portex NRFit Spinal Needles, Portex NRFit Loss ofJune 1, 2018