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

    UROPLASTY RIGID ENDOSCPIC NEEDLES

    K Number: K121337 · Decision Aug 3, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    98
    Registration Numbers
    98
    Same Product Code
    88
    Applicant Total
    8
    Review Days
    92

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    Basic Information

    Device Name
    UROPLASTY RIGID ENDOSCPIC NEEDLES
    K Number
    K121337
    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 3, 2012
    Decision Date
    August 3, 2012
    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

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    Other Clearances by Uroplasty, Inc.

    K Number Device Name
    K101847 URGENT PC STIMULATOR; URGENT PC LEAD SET
    K091391 UROPLASTY RIGID ENDOSCOPIC NEEDLE, MRN-518
    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