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

    INVISIJECT RESUSABLE AUTO-INJECTOR

    K Number: K032425 · Decision Nov 5, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    40
    Registration Numbers
    40
    Same Product Code
    46
    Applicant Total
    2
    Review Days
    91

    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
    INVISIJECT RESUSABLE AUTO-INJECTOR
    K Number
    K032425
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.6920
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Biogen
    Date Received
    August 6, 2003
    Decision Date
    November 5, 2003
    Product Code
    KZH
    Advisory Committee
    General Hospital
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

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

    Product Code Device Name
    KZH Introducer, Syringe Needle

    Similar 510(k) Clearances

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

    GripMate

    FDA 510(k)
    FDA Class 2 ·General Hospital

    AccuSert Needle Inserter

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Orbit Inserter

    FDA 510(k)
    FDA Class 2 ·General Hospital

    MiniMed Quick-serter

    FDA 510(k)
    FDA Class 2 ·General Hospital

    WHISPERJECT AUTOINJECTOR

    FDA 510(k)
    FDA Class 2 ·General Hospital

    LOBSTER AUTO-INJECTOR

    FDA 510(k)
    FDA Class 2 ·General Hospital
    View all

    Other Clearances by Biogen

    K Number Device Name
    K042314 SYRINGE GRIP FOR THE AVONEX PRE-FILLED SYRINGE