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510(k) Data Aggregation

    K Number
    K993970
    Device Name
    MICRINS MICROSURGICAL SUTURE
    Manufacturer
    MICRINS SURGICAL, INC.
    Date Cleared
    2000-03-30

    (128 days)

    Product Code
    GAR
    Regulation Number
    878.5020
    Why did this record match?
    Applicant Name (Manufacturer) :

    MICRINS SURGICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Micrins microsurgical suture is indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurological procedures.
    Device Description
    Not Found
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    K Number
    K982278
    Device Name
    MICRINS MICRO ANASTOMOSIS CLAMP
    Manufacturer
    MICRINS SURGICAL, INC.
    Date Cleared
    1999-03-26

    (270 days)

    Product Code
    DXC
    Regulation Number
    870.4450
    Why did this record match?
    Applicant Name (Manufacturer) :

    MICRINS SURGICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Micrins Micro Anastomosis Clamp is a hand held surgical instrument that is designed to be used in Microvascular Surgery to either temporarily occlude or approximate blood vessels during the anastomosis process. The clamps are available in three different size ranges and are to be used on vessels that range in size from 0.4mm to 2.25mm. The clamps are used to facilitate surgical procedures that are typically called "free flaps" or replants. Once the microanastomosis has been completed the micro clamp is removed from the patient
    Device Description
    The Micrins Micro Anastomosis Clamp is a hand held surgical instrument that is designed to be used in Microvascular Surgery to either temporarily occlude or approximate blood vessels during the anastomosis process. The clamps are available in three different size ranges and are to be used on vessels that range in size from 0.4mm to 2.25mm.
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