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510(k) Data Aggregation

    K Number
    K121343
    Device Name
    MODULAP LOOP
    Manufacturer
    ATC TECHNOLOGIES, INC.
    Date Cleared
    2013-06-14

    (406 days)

    Product Code
    KNF
    Regulation Number
    884.4160
    Why did this record match?
    Applicant Name (Manufacturer) :

    ATC TECHNOLOGIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Modulap Loop is intended for monopolar electrosurgical coagulation/cutting during laparoscopic surgery. It is indicated for the amputation of the uterus during supracervical hysterectomy and for resection of pedunculated subserosal (abdominal) myomas. It is not intended for use in hysteroscopy or for contraceptive coagulation of the fallopian tubes.
    Device Description
    The Modulap Loop is a 5 mm laparoscopic instrument. It consists of a standard insulated monopolar electrosurgical probe, with a flexible wire loop as its distal tip, and a sliding sheath constructed of insulating material. The wire loop is insulated except for a central approximately 1 inch cutting area. The device is a single-use sterile, disposable device. It is compatible with standard electrosurgical generators, and associated cables.
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    K Number
    K010473
    Device Name
    SPARROWHAWK DISPOSABLE
    Manufacturer
    ATC TECHNOLOGIES, INC.
    Date Cleared
    2001-06-06

    (106 days)

    Product Code
    DWZ
    Regulation Number
    870.4075
    Why did this record match?
    Applicant Name (Manufacturer) :

    ATC TECHNOLOGIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K994319
    Device Name
    MODULAP
    Manufacturer
    ATC TECHNOLOGIES, INC.
    Date Cleared
    2000-03-20

    (89 days)

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

    ATC TECHNOLOGIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Candidate Devices are intended for irrigation, evacuation of body fluids, and electrosurgical cutting/coagulation during general laparoscopic surgical procedures, (e.q. laparoscopic cholecystectorny, appendectomy and herniorrhaphy). They are not intended for use in hysteroscopy or for contraceptive coagulation of the Fallopian tube. The Candidate Devices are indicated for use in patients eligible for monopolar electrosurgical treatment via general laparoscopic surgical procedures.
    Device Description
    When used in conjunction with a legally-marketed irrigation pump, irrigant bag or bottle, suction source, electrosurgical generator and suction/irrigation trumpet valve, the Candidate Devices provide irrigation, suction and electrosurgical cutting and coagulation capabilities to the operative site during general laparoscopic surgical procedures. Provides electrosurgical cutting and coagulation to the surgical site during general laparoscopic surgical procedures by communicating the high-frequency electric current generated by a legally-marketed electrosurgical generator to the operative site. The Candidate Devices consist of a stainless steel cannula and connector used to communicate electrosurgical, suction, and irrigation capabilities to the operative site during laparoscopic surgical procedures.
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    K Number
    K983623
    Device Name
    MODULAP
    Manufacturer
    ATC TECHNOLOGIES, INC.
    Date Cleared
    1998-12-18

    (64 days)

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

    ATC TECHNOLOGIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Candidate Devices are intended for irrigation, evacuation of body fluids, and electrosurgical cutting/coagulation during general laparoscopic procedures, (e.g. laparoscopic cholecystectomy, appendectomy and herniorrhaphy). They are not intended for use in hysteroscopy or for contraceptive coagulation of the Fallopian tube. The Candidate Devices are indicated for use in patients eligible for monopolar electrosurgical treatment via general laparoscopic surgical procedures.
    Device Description
    The Candidate Devices consist of a stainless steel cannula and connector used to communicate electrosurgical, suction, and irrigation capabilities to the operative site during laparoscopic surgical procedures.
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