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

    UROMED NEEDLE GRASPER

    K Number: K974137 · Decision Jan 30, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    52
    Registration Numbers
    52
    Same Product Code
    69
    Applicant Total
    10
    Review Days
    88

    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
    UROMED NEEDLE GRASPER
    K Number
    K974137
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Uromed Corp.
    Date Received
    November 3, 1997
    Decision Date
    January 30, 1998
    Product Code
    OCW
    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
    OCW Endoscopic Tissue Approximation Device

    Similar 510(k) Clearances

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

    Endomina EZFuse system

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

    SimpleStitch Suturing System

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

    MaxTack™ Motorized Fixation Device

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

    MedicloseTM System

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

    OverStitch NXT Endoscopic Suturing System

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

    endomina system

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

    Other Clearances by Uromed Corp.

    K Number Device Name
    K010213 MODIFICATION TO CAVERMAP SURGICAL AID
    K010098 MODIFICATION TO CAVERMAP SURGICAL AID
    K000507 CAVERMAP SURGICAL AID
    K993436 CAVERMAP SURGICAL AID
    K982226 UROMED BRACHYTHERAPHY IODINE-125 SOURCES
    K980717 UROMED SLING KIT
    K974600 UROMED PATCH
    K970971 URO MED NERVE STIMULATOR
    K971992 UROMED ALTERNATIVE BLADDER CONTROL CONTINENCE DEVICE(ABCPN-0026)