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

    DYNABITE HOT GI BIOPSY FORCEPS

    K Number: K970083 · Decision Jun 17, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    52
    Registration Numbers
    52
    Same Product Code
    45
    Applicant Total
    8
    Review Days
    159

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    Basic Information

    Device Name
    DYNABITE HOT GI BIOPSY FORCEPS
    K Number
    K970083
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.4300
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Portlyn Corp.
    Date Received
    January 9, 1997
    Decision Date
    June 17, 1997
    Product Code
    KGE
    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
    KGE Forceps, Biopsy, Electric

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    Other Clearances by Portlyn Corp.

    K Number Device Name
    K951447 DYNABITE CARDIOVASCULAR BIOPSY FORCEPS
    K952391 DYNABITE UROLOGICAL FORCEPS
    K944245 DYNABITE LAPAROSCOPIC FORCEPS
    K934506 DYNABITE HYSTEROSCOPIC FORCEPS
    K901300 BIOPSY FORCEPS
    K896147 BIOPSY FORCEP (NON-ELECTRIC)
    K896146 BIOPSY FORCEPS, (NON-RIGID)