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

    MIST ENDOSCOPIC NEEDLES

    K Number: K951648 · Decision May 12, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    98
    Registration Numbers
    98
    Same Product Code
    88
    Applicant Total
    8
    Review Days
    32

    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
    MIST ENDOSCOPIC NEEDLES
    K Number
    K951648
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Mist, Inc.
    Date Received
    April 10, 1995
    Decision Date
    May 12, 1995
    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

    Disposable Endoscopic Injection Needles

    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
    View all

    Other Clearances by Mist, Inc.

    K Number Device Name
    K970937 MIST MICRO INTERCHANGEABLE SCOPE SYSTEM (TM)
    K971150 MIST PANORAMIC LAPAROSCOPE A RIGID LAPAROSCOPE
    K952290 MIST ELECTROSURGICAL PROBES, VARIOUS STYLES & SIZES, SURGICAL INSTRUMENTS USED DURING ENDOSCOPIC PROCEDURES
    K952323 MIST ELECTROSURGICAL PROBES, VARIOUS STYLES & SIZES
    K951692 MIST ENDOSCOPIC PROBES
    K951481 MIST ENDOSCOPIC CANNULAS
    K951480 MIST TROCARS