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

    BIOPSY FORCEPS

    K Number: K901300 · Decision Jun 29, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    25
    Registration Numbers
    25
    Same Product Code
    22
    Applicant Total
    8
    Review Days
    101

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    Basic Information

    Device Name
    BIOPSY FORCEPS
    K Number
    K901300
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.4075
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Portlyn Corp.
    Date Received
    March 20, 1990
    Decision Date
    June 29, 1990
    Product Code
    DWZ
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    CV
    Third Party
    N

    Classifications

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

    Product Code Device Name
    DWZ Device, Biopsy, Endomyocardial

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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
    K896147 BIOPSY FORCEP (NON-ELECTRIC)
    K896146 BIOPSY FORCEPS, (NON-RIGID)