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

    UROPLASTY RIGID ENDOSCOPIC NEEDLE, MRN-518

    K Number: K091391 · Decision Jun 30, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    98
    Registration Numbers
    98
    Same Product Code
    88
    Applicant Total
    8
    Review Days
    50

    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
    UROPLASTY RIGID ENDOSCOPIC NEEDLE, MRN-518
    K Number
    K091391
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Uroplasty, Inc.
    Date Received
    May 11, 2009
    Decision Date
    June 30, 2009
    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 Uroplasty, Inc.

    K Number Device Name
    K121337 UROPLASTY RIGID ENDOSCPIC NEEDLES
    K101847 URGENT PC STIMULATOR; URGENT PC LEAD SET
    K071822 URGENT PC NEUROMODULATION SYSTEM, MODELS UPC200 AND UPC250-12
    K061333 URGENT PC NEUROMODULATION SYSTEM, MODELS UPC200-A AND UPC250-12
    K052175 I-STOP MID-URETHRAL SLING, MODELS IS-1000, IS-2000, IS-3000, IS-4000
    K052025 URGENT PC NEUROMODULATION SYSTEM
    K051905 UROPLASTY RIGID ENDOSCOPIC NEEDLE