LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K983015
    Device Name
    VIRILIS PENILE PROSTHESIS
    Manufacturer
    SPECIALTY SURGICAL PRODUCTS, INC.
    Date Cleared
    1999-02-05

    (161 days)

    Product Code
    FTQ
    Regulation Number
    876.3630
    Why did this record match?
    Product Code :

    FTQ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Virilis Penile Prostheses are intended for implantation into the corpora cavernosa of the penis in patients who are diagnosed as having erectile dysfunction. The prosthesis is implanted to provid adequate penile rigidity for vaginal penetration.
    Device Description
    Virilis Penile Prostheses
    Ask a Question

    Page 1 of 1