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510(k) Data Aggregation

    K Number
    K140907
    Device Name
    LEECH, MEDICINAL
    Manufacturer
    CAROLINA BIOLOGICAL SUPPLY CO.
    Date Cleared
    2015-08-07

    (486 days)

    Product Code
    NRN
    Regulation Number
    N/A
    Why did this record match?
    Product Code :

    NRN

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Medicinal leeches may be used in instances where skin flaps, skin grafts, surgical reattachments, or other tissues are adversely affected by impaired venous blood flow. Leeches may be used to alleviate the problem of venous congestion and delayed healing by creating prolonged localized bleeding.
    Device Description
    The Medicinal Leech is a laboratory-raised bloodsucking annelid (segmented worm) that inhabits fresh water. The leech has a cylindrical body, is slightly flattened, and has around 32 segments. It has a disc-shaped sucker at the head end and a tail sucker at the caudal end.
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    K Number
    K132958
    Device Name
    MEDICINAL LEECHES
    Manufacturer
    BIOPHARM (UK) LTD.
    Date Cleared
    2014-02-19

    (152 days)

    Product Code
    NRN
    Regulation Number
    N/A
    Why did this record match?
    Product Code :

    NRN

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Leeches may be used in instances where skin flaps, skin grafts, or other tissues are suffering from impaired venous circulation. Leeches may be used to alleviate the problem of venous congestion by creating prolonged localized bleeding.
    Device Description
    The device is a European Medicinal Leech (Hirudo verbana). It is a greenish segmented worm of the Annelida worm classification. The animal is a bloodsucking animal living in freshwater.
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    K Number
    K040187
    Device Name
    MEDICINAL LEECHES
    Manufacturer
    RICARIMPEX SAS
    Date Cleared
    2004-06-21

    (145 days)

    Product Code
    NRN
    Regulation Number
    N/A
    Why did this record match?
    Product Code :

    NRN

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    An adjunct to the healing of graft tissue when problems of venous congestion may delay healing, or to when problems of venous congestion by creating prolonged localized bleeding.
    Device Description
    Medicinal Leeches, a blood sucking aquatic animal living in fresh water and subject to regulation by the U.S. Fish and Wildlife Service, are a preamendment, unclassified device which, by nature of their historical use and documented value in various post surgical situations.
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