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

    REPROCESSED SINGLE USE DEVICES BIOPSY FORCEPS

    K Number: K033593 · Decision Nov 20, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Same Product Code
    3
    Applicant Total
    14
    Review Days
    7

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    Basic Information

    Device Name
    REPROCESSED SINGLE USE DEVICES BIOPSY FORCEPS
    K Number
    K033593
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.4300
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Clearmedical, Inc.
    Date Received
    November 13, 2003
    Decision Date
    November 20, 2003
    Product Code
    NLU
    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
    NLU Forceps, Biopsy, Electric, Reprocessed

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    Other Clearances by Clearmedical, Inc.

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    K031416 CLEARMEDICAL/CRITIKON BLOOD PRESSURE CUFF; CLEARMEDICAL/WELCH ALLYN BLOOD PRESSURE CUFF
    K012600 CLEARMEDICAL/NELLCOR OXISENSOR II, ADULT, MODEL D-25/D-25L
    K012622 CLEARMEDICAL/NELLCOR OXISENSOR II, PEDIATRIC, MODEL D-20
    K012609 CLEARMEDICAL/NELLCOR OXISENSOR II, NEONATAL/ADULT, MODEL N-25
    K012601 CLEARMEDICAL/AIRCAST VENAFLOW CALF CUFF, CLEARMEDICAL AIRCAST XL VENAFLOW CALF CUFF, CLEARMEDICAL/AIRCAST VENAFLOW THIGH
    K012621 CLEARMEDICAL/HENTLEIGH DEEP VEIN THROMBOSIS (DVT) GARMENT
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