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

    WILTEK BIOPSY FORCEPS

    K Number: K930419 · Decision Jun 1, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    7
    Registration Numbers
    7
    Same Product Code
    5
    Applicant Total
    21
    Review Days
    126

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    Basic Information

    Device Name
    WILTEK BIOPSY FORCEPS
    K Number
    K930419
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    874.4680
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Wiltek Medical, Inc.
    Date Received
    January 26, 1993
    Decision Date
    June 1, 1993
    Product Code
    BWH
    Advisory Committee
    Ear, Nose, Throat
    Review Advisory Committee
    EN
    Third Party
    N

    Classifications

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

    Product Code Device Name
    BWH Forceps, Biopsy, Bronchoscope (Non-Rigid)

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    Other Clearances by Wiltek Medical, Inc.

    K Number Device Name
    K990231 WILTEK HOT BIOPSY FORCEPS
    K922989 WILTEK IRRIGAITON/ASPIRATION TUBE SET
    K914882 WILTEK BALLOON CHOLANGIOGRAPHY CATHETER
    K914881 WILTEK LAPAROSCOPIC CHOLANGIOGRAPHY CATHETER
    K914132 WILTEK ELECTROCAUTERY ACTIVE CORD
    K914131 WILTEK ELECTROCAUTERY ADAPTOR
    K912122 CHOLANGIOGRAPHY CATHETER
    K912288 WILTEK STANDARD CHOLANGIOGRAPHY CATHETER
    K910334 ELECTROCAUTERY PROBE
    K894866 WILTEK STONE EXTRACTOR
    Search all 21 clearances from Wiltek Medical, Inc. →