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

    AMS SLING FIXATION SYSTEM

    K Number: K010990 · Decision Jun 22, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    108
    Registration Numbers
    108
    Same Product Code
    84
    Applicant Total
    72
    Review Days
    80

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    Basic Information

    Device Name
    AMS SLING FIXATION SYSTEM
    K Number
    K010990
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.5010
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    American Medical Systems, Inc.
    Date Received
    April 3, 2001
    Decision Date
    June 22, 2001
    Product Code
    GAW
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    GAW Suture, Nonabsorbable, Synthetic, Polypropylene

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    Other Clearances by American Medical Systems, Inc.

    K Number Device Name
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    K092735 GREENLIGHT XPS LASER SYSTEM
    K090934 PFR SLING SYSTEM, PART OF THE AMS PELVIC FLOOR REPAIR SYSTEM
    K090663 AMS SPECTRA CONCEALABLE PENILE PROSTHESIS
    K090713 ELEVATE PROLAPSE REPAIR SYSTEM WITH PC COATED INTEPRO LITE- APICAL AND POSTERIOR PROLAPSE REPAIR SYSTEM, ANTERIOR AND AP
    K082677 AMS ELEVATE ANTERIOR & APICAL PROLAPSE REPAIR SYSTEM WITH INTEPRO LITE
    K082730 AMS ELEVATE APICAL AND POSTERIOR PROLAPSE REPAIR SYSTEM WITH INTEPRO LITE, AMS ELEVATE APICAL AND POSTERIOR PROLAPSE
    K082006 AMS SPECTRA CONCEALABLE PENILE PROSTHESIS
    Search all 72 clearances from American Medical Systems, Inc. →