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

    BIOPSY SCIENCES, LLC. MAXI-CELL BIOPSY NEEDLES

    K Number: K021847 · Decision Sep 3, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    128
    Registration Numbers
    128
    Same Product Code
    132
    Applicant Total
    8
    Review Days
    90

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    Basic Information

    Device Name
    BIOPSY SCIENCES, LLC. MAXI-CELL BIOPSY NEEDLES
    K Number
    K021847
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1075
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Biopsy Sciences, LLC
    Date Received
    June 5, 2002
    Decision Date
    September 3, 2002
    Product Code
    FCG
    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
    FCG Biopsy Needle

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    Other Clearances by Biopsy Sciences, LLC

    K Number Device Name
    K130537 BIOPSY SCIENCES LLC HYDROMARK BREAST BIOPSY SITE MARKER
    K121113 BIOPSY SCIENCES, INC. HYDROMARK BREST BIOSY SITE MARKER
    K090501 BIOPSY SCIENCES HYDROMARK BREAST BIOPSY SITE MARKER, MODELS 4005-02-15-T1, 4005-02-15-S1, 4005-03-15-T1, 4005-03-15-S1
    K083006 BIOPSY SCIENCES, INC., HYDROMARK BREAST BIOPSY SITE MARKER
    K060769 HYDROMARK BIOPSY SITE MARKER
    K041331 BIOPSY SCIENCES, LLC, LUNG BIOPSY SITE MARKER
    K023694 BIO-MARK RESORBABLE BIOPSY SITE MARKER AND BIO-MARK PERMANENT BIOPSY SITE MARKER