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

    SILICONE BILIARY STENT/BILIARY CATHETER

    K Number: K973114 · Decision Sep 19, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    143
    Registration Numbers
    143
    Same Product Code
    473
    Applicant Total
    12
    Review Days
    30

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    Basic Information

    Device Name
    SILICONE BILIARY STENT/BILIARY CATHETER
    K Number
    K973114
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5010
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Specialty Surgical Products, Inc.
    Date Received
    August 20, 1997
    Decision Date
    September 19, 1997
    Product Code
    FGE
    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
    FGE Stents, Drains And Dilators For The Biliary Ducts

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    Other Clearances by Specialty Surgical Products, Inc.

    K Number Device Name
    K140383 ALLOX2 TISSUE EXPANDERS
    K984106 MAMMARY SIZER, MAMMARY PROTHESIS SIZER
    K983015 VIRILIS PENILE PROSTHESIS
    K982258 MAMMARY SIZER
    K982065 STERILE SILICONE EXTERNAL WOUND COVER
    K982067 MAGNETIC PORT SILICONE TISSUE EXPANDER
    K974653 SILICONE ELASTOMER SHEETING
    K974654 SILICONE BLOCKS
    K974209 SILICONE TISSUE/INFLATABLE TISSUE EXPANDER
    K973656 DISPOSABLE SILICONE EPISTAXIS CATHETER
    Search all 12 clearances from Specialty Surgical Products, Inc. →