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

    SimpleStitch Suturing System

    K Number: K243750 · Decision Apr 17, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    52
    Registration Numbers
    52
    Same Product Code
    69
    Applicant Total
    2
    Review Days
    133

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    Basic Information

    Device Name
    SimpleStitch Suturing System
    K Number
    K243750
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Envision Endoscopy
    Date Received
    December 5, 2024
    Decision Date
    April 17, 2025
    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

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    Other Clearances by Envision Endoscopy

    K Number Device Name
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