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510(k) Data Aggregation

    K Number
    K170423
    Device Name
    DentureID Microchip
    Manufacturer
    CMP Industries LLC
    Date Cleared
    2017-10-25

    (254 days)

    Product Code
    PYQ, LWH, NRV, OUG
    Regulation Number
    880.6300
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    DentureID Microchip is intended to enable access to secure patient identification and device information when used with complete dentures, partial dentures and other removable oral appliances.
    Device Description
    DentureID Microchip enables access to secure patent identification and device information when used with removable oral appliances. The microchip is permanently embedded into a denture and is a digital link to owner contact information and information about the denture in the event that a repair or replacement is needed. All of the information is controlled on the secure DentureID.com website by the denture owner and dental professional. The DentureID Microchip can be read by any NFC compatible Android Smart Phone (after downloading the DentureID.com App from Google Play) and holding the phone against the microchip. The information on the DentureID.com website may be modified at any time by the patient or dental professional by entering a username and password. The information that is on the website will appear on the smart phone when reading the DentureID Microchip. DentureID Microchips are classified as RFID ISO 14443 which use NFC (near-field-communication). DentureID Microchips are designed to be read by ISO 14443 NFC-compliant smart phones with DentureID App installed. DentureID Microchips are encased in a medical-grade epoxy resin. The size is 1.5mm X 6 mm in diameter. They are inserted into the buccal flange of a denture and completely covered with self-cure repair resin. The DentureID Microchip does not directly contact the patient.
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    K Number
    K121274
    Device Name
    PIXEL APP
    Manufacturer
    GAUSS SURGICAL, INC.
    Date Cleared
    2012-06-27

    (61 days)

    Product Code
    LWH
    Regulation Number
    880.2740
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Gauss Pixel App is intended to be used to aid current clinical practices in recording the number of surgical sponges and for visibility for assessment of sponge images.
    Device Description
    Not Found
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    K Number
    K120473
    Device Name
    PIXEL APP
    Manufacturer
    GAUSS SURGICAL, INC.
    Date Cleared
    2012-04-09

    (53 days)

    Product Code
    LWH
    Regulation Number
    880.2740
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Gauss Pixel App is indicated for use to aid current practices in recording the number of surgical sponges and for visibility for assessment of sponge images.
    Device Description
    The Gauss Pixel App is a software program used on an iPad tablet to capture images of sponges to assist surgical personnel in the management of surgical sponges after surgical The App allows surgical personnel to categorize sponges by sponge type and use. provides an automated ongoing count of total sponge images and sponge images by tag. It also provides a visual record of images for further evaluation. This program is not intended to replace existing sponge counting practices and sponges should be retained per the user's standard sponge management practice until the case is complete and sponge counting has been finalized.
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    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
    K093557
    Device Name
    SMARTWAND-DTX
    Manufacturer
    CLEARCOUNT MEDICAL SOLUTIONS
    Date Cleared
    2009-12-18

    (32 days)

    Product Code
    LWH
    Regulation Number
    880.2740
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ClearCount Medical Solutions SmartWand-DTX™ System is indicated for use in counting and displaying the number of RFID-tagged surgical sponges, laparatomy sponge, and towels detected by the device and providing a noninvasive means of locating retained RFID-tagged surgical sponges, towels, and other tagged items within a surgical site.
    Device Description
    The SmartWand-DTX™ System is based on radio frequency identification (RFID) tags. The RFID tags are provided to manufacturers of surgical disposables for inclusion into their surgical sponges, laparotomy pads and surgical towels. The disposable manufacturer permanently attaches the RFID tags to the gauze or fabric of the disposables. The tags are then programmed to contain information about the type and number of disposables in the package. This allows the sponges, pads, and towels to be individually recognized by an RFID reader. The RFID tag function is the same as that for the SmartSponge Plus System. The SmartWand-DTX is a device comprised of a handheld scanning antenna that is attached to an electronics box that contains an RFID reader and supporting electronics. Integrated RFID technology allows the capture of the information coded on the unique RFID tags in the sponges, pads and towels. When the tagged sponges, pads, and towels are detected by the scanning wand, the device displays the type and number of each type of item that is detected. The system recognizes RFID-tagged items that may be inside the surgical site.
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    K Number
    K073180
    Device Name
    SMARTSPONGE PLUS SYSTEM
    Manufacturer
    CLEARCOUNT MEDICAL SOLUTIONS, INC.
    Date Cleared
    2007-11-19

    (6 days)

    Product Code
    LWH
    Regulation Number
    880.2740
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ClearCount Medical Solutions SmartSponge™ PLUS System is indicated for use in counting and recording the number of RFID-tagged surgical sponges, laparatomy sponges and towels used during surgical procedures, as well as for providing a non-invasive means of locating retained RFID-tagged surgical sponges, towels, and other tagged items within a surgical site.
    Device Description
    The SmartSponge™ PLUS System includes surgical sponges, laparatomy pads and surgical towels, each 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. A Detection Wand is an additional antenna that is tethered by a cable to the SmartBucket. It is powered and controlled by the SmartBucket. The antenna functions as an additional RFID antenna to the system, functioning in an identical manner to the internal SmartBucket antennas. By using a keypad the user may select activate the Detection Wand antenna. When in Detection Wand mode, the system uses the Wand antenna to recognize RFID-tagged items that may be inside the surgical site. A Detection Mat is a disposable or reusable element with multiple RFID tags embedded inside, along with several passive printed circuit traces. Like the RFID-tagged sponges, the Detection Mat tags contain unique identifying numbers and are distinguishable by the system software. The Detection Mat is placed on the operating room table before the patient is brought into the room and is covered by the standard sheets or drapes used in surgery, thus not making contact with the patient. The RFID tags in the Matt provide feedback to the user that the Detection Wand is being held close enough to the patient to ensure proper reading. The tags in the Detection Mat also ensure that the Detection Wand scan has covered the appropriate areas of the patient. The passive circuit traces help to enhance the readability of the RFID tags in the Detection Mat.
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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
    K061316
    Device Name
    MEDLINE SURGICAL SPONGE SCANNER
    Manufacturer
    MEDLINE INDUSTRIES, INC.
    Date Cleared
    2006-11-02

    (175 days)

    Product Code
    LWH
    Regulation Number
    880.2740
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Medline Surgical Sponge Scanning System is intended to be used to augment current sponge counting practice by providing a means to electronically detect potentially retained springes,
    Device Description
    Not Found
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    K Number
    K062642
    Device Name
    RF SURGICAL SYSTEMS INC. DETECTION SYSTEM, MODEL 100A
    Manufacturer
    RF SURGICAL SYSTEMS, INC.
    Date Cleared
    2006-11-02

    (57 days)

    Product Code
    LWH
    Regulation Number
    880.2740
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The RF Surgical Systems Inc. Detection System is intended to provide a non-invasive means of locating retained surgical sponges, gauze and other tagged items within a surgical site. It is to be employed as an adjunctive detection method to current surgical sponge and gauze counting systems and methods
    Device Description
    The RF Surgical Systems Inc. Detection System consists of: 1. The Power/Control Console contains the electronics that power and control the detector/scanner. The console also includes the user interface for system operation and communication of the system status, operation and alarms to the user. 2. The Transponder/Tag is a single use electrically passive device that is designed to radiate a magnetic signature when stimulated by magnetic impulses from the detector/scanner. The tag does not store or communicate any information or unique code and is to be mechanically attached to guaze sponges at the manufacturing site and processed as part of the item 3. The Detection Wand is a transceiver type antenna designed to stimulate the transponder tag assembly with magnetic impulses and then detect the resultant magnetic signature from the tag. The Power/Control Console provides the power and control to the detection scanner. The detection scanner is intended and designed to be a single-use disposable device and will be supplied in a sterile condition as it will enter the surgical field.
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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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