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510(k) Data Aggregation

    K Number
    K012279
    Device Name
    PATTON TRIPOL
    Manufacturer
    PATTON MEDICAL CORP.
    Date Cleared
    2002-04-30

    (285 days)

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

    PATTON MEDICAL CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Patton Tripol™ is intended for use in open and laparoscopic surgeries where grasping, coagulating, and transecting of tissue is indicated.
    Device Description
    The Patton Tripol™ is a forceps that grasps, coagulates, and transects tissue, utilizing electrical current. The device is compatible with available bipolar generators.
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    K Number
    K012150
    Device Name
    PATTON ENDO-BAG
    Manufacturer
    PATTON MEDICAL CORP.
    Date Cleared
    2001-09-20

    (72 days)

    Product Code
    GCJ
    Regulation Number
    876.1500
    Why did this record match?
    Applicant Name (Manufacturer) :

    PATTON MEDICAL CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Patton Endo-Bag is a single use retrieval bag designed to temporarily contain organs or tissues and facilitates their removal from the patient without contamination, during laparoscopic surgery.
    Device Description
    The Patton Endo-Bag™ is a single-use retrieval bag designed to temporarily contain organs or stones, and facilitate their removal from the patient without contamination during laparascopic surgery.
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    K Number
    K991963
    Device Name
    PATTON SPECULUM
    Manufacturer
    PATTON MEDICAL CORP.
    Date Cleared
    1999-09-01

    (83 days)

    Product Code
    HIB
    Regulation Number
    884.4530
    Why did this record match?
    Applicant Name (Manufacturer) :

    PATTON MEDICAL CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Patton Speculum™ is intended for use to retract the vagina in diagnostic and therapeutic obstetrical and gynecological procedures.
    Device Description
    The Patton Speculum™ is a handheld mechanical device with a pistol-grip handle, four retracting blades, and a ratchet lock. When the handle is squeezed, the blades move in such a way as to expand the cylindrical surface enclosing them.
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    K Number
    K992324
    Device Name
    FUNNEL TROCAR
    Manufacturer
    PATTON MEDICAL CORP.
    Date Cleared
    1999-08-19

    (38 days)

    Product Code
    GCJ
    Regulation Number
    876.1500
    Why did this record match?
    Applicant Name (Manufacturer) :

    PATTON MEDICAL CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Funnel Trocar™ is an access device for laparoscopic procedures. The new instrument creates and maintains a passageway for laparoscopic instruments during a variety of general, gynecologic, thoracic, and urological procedures.
    Device Description
    The Funnel Trocar™ is a disposable single patient use device fabricated from surgical grade stainless steel, and biocompatible medical grade polymers. The device is available in a variety of diameters (5mm. 7/8mm. 12mm) and lengths (55mm. 70mm, and 100mm). The Funnel Trocar™ is supplied with either a shielded cutting obturator (trocar). The cannula is equipped with a luer fitting to provide access for insufflation of the operative area. The cannula is available with or without stability threads.
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