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510(k) Data Aggregation

    K Number
    K973259
    Device Name
    K&W 2-PIECE TAKE-APART INSTRUMENTS(VARIOUS)
    Manufacturer
    MEDICAL CREATIVE TECHNOLOGIES, INC.
    Date Cleared
    1997-09-10

    (12 days)

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

    MEDICAL CREATIVE TECHNOLOGIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For use in endoscopic surgical procedures through cannulae to perform cutting, grasping, dissecting, retracting, and manipulating functions.
    Device Description
    The K&W 2-Piece Take-Apart Instrumentation are endoscopic instruments which have jaws designed to cut, grasp, dissect, retract, and manipulate. The reusable handles are offered in both insulated and noninsulated actuating rings that adapt to various interchangeable jaw configurations with integral shafts. The shaft of the jaws fits into the handle and can be taken apart for cleaning. The jaws are rotated by turning the knob on the handle.
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    K Number
    K962147
    Device Name
    DEXTERITY PNEUMO SLEEVE SET
    Manufacturer
    MEDICAL CREATIVE TECHNOLOGIES, INC.
    Date Cleared
    1996-07-09

    (36 days)

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

    MEDICAL CREATIVE TECHNOLOGIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Dexterity® Pneumo Sleeve is intended to provide abdominal access for the surgeon's hand while preserving pneumoperitoneum during laparoscopic surgery. The Protector® Retractor is intended to provide incision retraction and to protect it against wound contamination during both laparoscopic and open surgery. This device allows the surgeon to use his hand while performing corrective surgery in the abdominal cavity under pneumoperitoneum.
    Device Description
    The Dexterity® Pneumo Sleeve is a sterile, disposable device. It prevents leakage of CO2 and provides an extension of the pneumoperitoneum. It has an adhesive flange at one end that is placed over the inoision and adhered to the patient's abdomen. A velcro strap at the other end is used to tighten the Sleeve around the surgeon's arm. The Protector® Retractor is a sterile, disposable device. The Retractor consists of an open-ended cylinder with a flexible ring at each end. One ring is inserted through the incision into the peritoneal cavity while the other remains outside the incision. The Retractor holds the incision open and protects it against wound contamination.
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    K Number
    K954824
    Device Name
    PROTECTOR RETRACTOR & PROTECTOR RETRACTOR WITH DRAPE
    Manufacturer
    MEDICAL CREATIVE TECHNOLOGIES, INC.
    Date Cleared
    1996-04-23

    (186 days)

    Product Code
    KKX
    Regulation Number
    878.4370
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDICAL CREATIVE TECHNOLOGIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This device is to be used to protect and retract an incision in the abdominal wall. This is accomplished by placing one o-ring through the incision into the peritoneum cavity while the other o-ring remains outside of the incision. The outside o-ring is then rolled down against the skin. This lines the wound to protect against contamination and holds the incision open.
    Device Description
    The PROTECTOR® Retractor is a sterile, disposable device. The PROTECTOR® Retractor consists of an open-ended cylinder with a flexible o-ring at each end. The PROTECTOR® Retractor with a drape is the same configuration, except that it has a drape that is an integral part of it.
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