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510(k) Data Aggregation

    K Number
    K100551
    Device Name
    ORLOCATE SYSTEM MODEL ORL 100
    Manufacturer
    HALDOR ADVANCED TECHNOLOGIES LTD
    Date Cleared
    2010-08-12

    (167 days)

    Product Code
    LWH
    Regulation Number
    880.2740
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ORLocate™ system is indicated for use in recording and counting the number of RFID-tagged surgical sponges, laparotomy sponges, towels and other tagged items used during surgical procedures in which counting is required. In addition, the product is indicated for providing a non-invasive means of detecting retained RFID-tagged surgical sponges, towels and other tagged items within a surgical site, as an adjunctive detection method to current surgical counting systems and methods.
    Device Description
    Haldor ORLocate™ system is an RFID system providing a solution that enables the enumeration of sponges and surgical manual instruments, utilizing passive tags for keeping track of the items during surgery and to identify counting problems. In addition, the system provides a non-invasive means of locating retained surgical items within a surgical site. The submission consists of the ORLocate™ system which includes: cart and antennas. Additionaly the submission includes accessories which are: associated single use surgical sponges, gauzes, pads and surgical towels each fitted with a uniquely coded RFID tag and uniquely coded RFID tag used for surgical instruments. The RF frequency the system uses is 13.56 MHz according to ISO 15693. The system supplies also a semi-automatic application to help in counting untagged items, the count information is first entered manually and the calculations are automatic.
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    K Number
    K071355
    Device Name
    SMARTSPONGE SYSTEM
    Manufacturer
    CLEARCOUNT MEDICAL SOLUTIONS, INC.
    Date Cleared
    2007-05-24

    (9 days)

    Product Code
    LWH, GDY
    Regulation Number
    880.2740
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ClearCount Medical Solutions SmartSponge™ System is indicated for use in counting and recording the number of RFID-tagged surgical sponges, laparatomy sponges and towels used during surgical procedures.
    Device Description
    The SmartSponge™ System includes surgical sponges, laparatomy pads and surgical towels, each unit of which contains a unique radio frequency identification (RFID) tag permanently attached to the gauze or fabric. The tags allow the sponges and towels to be individually recognized by an RFID reader. The SmartBucket is a specially designed cart containing a microcontroller unit with specialized software designed for mobile data collection. Integrated RFID technology allows capture of the information coded on the unique RFID tag on the sponges, pads and towels. The microcontroller unit counts the initial number of sponges introduced into a surgical case, and using the custom software program, reports the total sponges discarded at the end of the procedure, and compares that number to the original. By providing a count of the items entered into surgery, and a count of those discarded and removed permanently from the surgical field, personnel can be alerted to sponges that may still remain in the surgical field prior to closing the patient.
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    K Number
    K060076
    Device Name
    SURGICOUNT SAFETY-SPONGE SYSTEM
    Manufacturer
    SURGICOUNT MEDICAL
    Date Cleared
    2006-03-14

    (63 days)

    Product Code
    LWH
    Regulation Number
    880.2740
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SurgiCount Medical Safety-Sponge System™ is indicated for use in counting and recording the number of thermally labeled surgical sponges, laparotomy sponges and towels used during surgical procedure.
    Device Description
    The Safety Sponges include surgical sponges, laparatomy pads and surgical towels, each unit of which contains a unique identification label permanently fused to the gauze or fabric. The labels allow the sponges and towels to be individually recognized by a commercially available sight laser imager. The Safety Sponge Counter is a commercially available mobile computer with specialized software designed for mobile data collection. Integrated imaging technology allows capture of the information coded in the unique identification label on the sponges, pads and towels. The computer counts the initial number of sponges opened, and using the custom software program, reports the total sponges used at the end of the procedure or on demand, and compares that number to the original. Individual sponges may be identified as entered into the surgical field but not discarded, so that the surgical field can be explored before surgically closing the patient.
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    K Number
    K964029
    Device Name
    EMERGENCY RELIEF KIT SYSTEM
    Manufacturer
    BAXTER HEALTHCARE CORP.
    Date Cleared
    1997-03-17

    (161 days)

    Product Code
    LRR
    Regulation Number
    N/A
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Baxter Emergency Relief TM System consists of color-coded mini first aid kits. Each kit is intended to be used as a basic first aid treatment for various emergency situations, while seeking further professional medical assistance.
    Device Description
    The Baxter Emergency Relief ™ System is designed as one large unit which houses various first aid kits Each mini kit contains various individual components traditionally used for first aid treatment. Each individual component is a finished good with an established regulatory path where applicable. All components are purchased as finished goods and packaged in the appropriate mini kit, including direction for use inserts. All direction for use inserts correspond to the instruction manual accompanying the system.
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    K Number
    K960236
    Device Name
    CPR LAP SPONGES
    Manufacturer
    CUSTOM PACK RELIABILITY
    Date Cleared
    1996-03-28

    (72 days)

    Product Code
    GDY, FRG, GER
    Regulation Number
    878.4450
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Removal of suture from the epidermis.
    Device Description
    Not Found
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