BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇳 China

    Disposable Endoscopic Injection Needles

    K Number: K252021 · Decision Dec 2, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    98
    Registration Numbers
    98
    Same Product Code
    88
    Applicant Total
    1
    Review Days
    155

    Basic Information

    Device Name
    Disposable Endoscopic Injection Needles
    K Number
    K252021
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Changzhou New Med Micro-Medtech Co., Ltd.
    Date Received
    June 30, 2025
    Decision Date
    December 2, 2025
    Product Code
    FBK
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    GU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    FBK Endoscopic Injection Needle, Gastroenterology-Urology

    Similar 510(k) Clearances

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

    Injection Needle

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    InjecSURE Injection System

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    Injector Force Max Single Use Injector (NM-400L); Injector Force Max Single Use Injector (NM-400U); Injector Force Max Single Use Injector (NM-400Y); Injector Force Max Single Use Injector (NM-401L)

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    EzVu Visual Vasopressor injector (EV-19)

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    Endoscopic Injection Needles

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    injeTAK Adjustable Tip Needle (DIS199; DIS201)

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology
    View all