BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    BIOPSY FORCEP (NON-ELECTRIC)

    K Number: K896147 · Decision Apr 16, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    188
    Registration Numbers
    188
    Same Product Code
    38
    Applicant Total
    8
    Review Days
    175

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    Basic Information

    Device Name
    BIOPSY FORCEP (NON-ELECTRIC)
    K Number
    K896147
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    876.1075
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    Portlyn Corp.
    Date Received
    October 23, 1989
    Decision Date
    April 16, 1990
    Product Code
    FCL
    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
    FCL Forceps, Biopsy, Non-Electric

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    Other Clearances by Portlyn Corp.

    K Number Device Name
    K970083 DYNABITE HOT GI BIOPSY FORCEPS
    K951447 DYNABITE CARDIOVASCULAR BIOPSY FORCEPS
    K952391 DYNABITE UROLOGICAL FORCEPS
    K944245 DYNABITE LAPAROSCOPIC FORCEPS
    K934506 DYNABITE HYSTEROSCOPIC FORCEPS
    K901300 BIOPSY FORCEPS
    K896146 BIOPSY FORCEPS, (NON-RIGID)