BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    BD Quincke Spinal NRFit Needle, BD Whitacre Spinal NRFit Needle, BD Spinal Introducer NRFit Needle

    K Number: K193131 · Decision Sep 29, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    136
    Registration Numbers
    136
    Same Product Code
    151
    Applicant Total
    134
    Review Days
    322

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    BD Quincke Spinal NRFit Needle, BD Whitacre Spinal NRFit Needle, BD Spinal Introducer NRFit Needle
    K Number
    K193131
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5150
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Becton, Dickinson and Company
    Date Received
    November 12, 2019
    Decision Date
    September 29, 2020
    Product Code
    BSP
    Advisory Committee
    Anesthesiology
    Review Advisory Committee
    AN
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    BSP Needle, Conduction, Anesthetic (W/Wo Introducer)

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (BSP), ordered by most recent decision date.

    SonoMSK

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    SonoPlex STIM; SonoPlex II

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    SPROTTE® STANDARD (LUER/ NRFit®) Lumbar Puncture

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    SonoTAP and SonoTAP II

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    SPROTTE® STANDARD (LUER/ NRFit®) Anesthesiology

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    SonoBlock; SonoBlock II

    FDA 510(k)
    FDA Class 2 ·Anesthesiology
    View all

    Other Clearances by Becton, Dickinson and Company

    K Number Device Name
    K260128 BD Preset™ and BD A-Line™ Arterial Blood Collection Syringes
    K252506 BD Vacutainer® Safety-Lok™ Blood Collection Set; BD Vacutainer® Safety-Lok™ Blood Collection Set with Pre-Attached Holder
    K252378 BD® MiniDraw™ Capillary Blood Collection System with BD® MiniDraw™ SST™ Capillary Blood Collection Tube
    K260184 Onclarity™ Self-Collection Kit
    K252040 BD Vacutainer® Plasma Separator Tubes (PST™), BD Vacutainer® Sodium Heparin Blood Collection Tubes
    K250884 0.9 % Sodium Chloride Injection, USP, BD PosiFlush™ SP Syringe
    K250358 BD Enteric Bacterial Panel for BD COR System, BD Enteric Bacterial Panel plus for BD COR System, and Enteric Bacterial Panel Diluent for BD COR System
    K250059 BD PhaSeal™ Optima Connecting Set (C83-O); BD PhaSeal™ Optima Spike Set (C180-O)
    K251713 BD Phoenix Automated Microbiology System - GN Eravacycline (0.125-2 µg/mL)
    K251350 BD Plastipak™ Syringe
    Search all 134 clearances from Becton, Dickinson and Company →