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

    REMEEX SYSTEM FOR URINARY INCONTINENCE

    K Number: K033310 · Decision Jan 15, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    28
    Registration Numbers
    28
    Same Product Code
    64
    Applicant Total
    3
    Review Days
    93

    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
    REMEEX SYSTEM FOR URINARY INCONTINENCE
    K Number
    K033310
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.3300
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Specialities Remeex International, S.L.
    Date Received
    October 14, 2003
    Decision Date
    January 15, 2004
    Product Code
    OTN
    Advisory Committee
    General, Plastic Surgery
    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
    OTN Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator

    Similar 510(k) Clearances

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

    Advantage Ultra System, Advantage Fit Ultra System, Lynx Ultra System

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    ArcSP Suprapubic Sling System

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    ArcTO Transobturator Sling System

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    Desara TV EZ 3.0 System, Desara Blue TV EZ 3.0 System, Desara TV EZ 2.7 System, Desara Blue TV EZ 2.7 System

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    Advantage Ultra System, Advantage Fit Ultra System, Lynx Ultra System

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    Athena Surgical RMUS System

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery
    View all

    Other Clearances by Specialities Remeex International, S.L.

    K Number Device Name
    K063136 NEEDLELESS SLING
    K062341 MALE REMEEX SYSTEM