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510(k) Data Aggregation

    K Number
    K000911
    Device Name
    MICROGRASP BIPOLAR COAGULATOR, MODELS 90048-90057
    Manufacturer
    HYSTERX, INC.
    Date Cleared
    2000-04-14

    (24 days)

    Product Code
    GEI
    Regulation Number
    878.4400
    Why did this record match?
    Applicant Name (Manufacturer) :

    HYSTERX, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K993695
    Device Name
    LIGA-LOOP SUTURE APPLICATOR
    Manufacturer
    HYSTERX, INC.
    Date Cleared
    2000-04-13

    (163 days)

    Product Code
    GAL, GAM, GAP, GEA
    Regulation Number
    878.4830
    Why did this record match?
    Applicant Name (Manufacturer) :

    HYSTERX, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The LIGA-LOOP Suture Applicator is intended for use in the suturing of soft tissue and ligation of blood vessels during open and guidance-assisted surgical procedures. The LIGA-LOOP Suture Applicator with polyglycolic acid (PGA) suture and the LIGA-LOOP Suture Applicator with gut suture (plain and chromic) are intended for the same use, excluding cardiovascular and neurological procedures.
    Device Description
    The LIGA-LOOP™ Suture Applicator is an instrument designed for ligation of soft tissue and blood vessels during surgical procedures. The device also incorporates a central lumen for use in irrigation and/or imaging to increase patient safety during suturing. The LIGA-LOOP™ Suture Applicator contains similar materials, is of similar design, and has the same operating principle as the predicate devices.
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    K Number
    K992714
    Device Name
    MICROGRASP MONOPOLAR COAGULATOR, MODEL NOS 90001-90010
    Manufacturer
    HYSTERX, INC.
    Date Cleared
    1999-10-05

    (54 days)

    Product Code
    GEI
    Regulation Number
    878.4400
    Why did this record match?
    Applicant Name (Manufacturer) :

    HYSTERX, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The MicroGRASP Monopolar Coagulator is indicated for use in the grasping and coagulation of soft tissue and blood vessels up to 3 mm during open and guidance-assisted surgical procedures.
    Device Description
    The MicroGRASP Monopolar Coagulator is an instrument designed for grasping and coagulation of soft tissue and blood vessels during surgical procedures. The MicroGRASP Monopolar Coagulator contains materials similar to those used in the predicate device, is of similar design and has the same operating principle as the predicate device.
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