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510(k) Data Aggregation

    K Number
    K110687
    Device Name
    RELIEVA STRATUS PRO MICROFLOW SPACER (FRONTAL)
    Manufacturer
    ACCLARENT, INC.
    Date Cleared
    2011-10-07

    (210 days)

    Product Code
    KAM
    Regulation Number
    878.4800
    Why did this record match?
    Product Code :

    KAM

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The MicroFlow Spacer (Frontal) is indicated for use as a postoperative spacer to maintain an opening to the frontal sinuses within the first 14 days following surgery. The MicroFlow Spacer also helps to prevent obstruction.
    Device Description
    The Relieva Stratus Pro MicroFlow Spacer (Frontal) is a device that maintains an opening at the target sinus for up to 14 days postoperatively. The device can be manually removed during an office follow-up visit.
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    K Number
    K093594
    Device Name
    MODIFICATION TO RELIEVA STRATUS MICROFLOW SPACER
    Manufacturer
    ACCLARENT, INC.
    Date Cleared
    2010-03-03

    (104 days)

    Product Code
    KAM
    Regulation Number
    878.4800
    Why did this record match?
    Product Code :

    KAM

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The MicroFlow Spacer (Frontal) is indicated for use as a postoperative spacer to maintain an opening to the frontal sinuses within the first 14 days following surgery. The MicroFlow Spacer also helps to prevent obstruction. The MicroFlow Spacer (Ethmoid) is indicated for use as a postoperative spacer to maintain an opening to the ethmoid sinuses within the first 14 days following surgery. The MicroFlow Spacer also helps to prevent obstruction.
    Device Description
    The MicroFlow Spacer is a device that maintains an opening at the target sinus for up to 14 days postoperatively. There are two models of the MicroFlow Spacer: Ethmoid and Frontal. The modified device can be manually removed during an office follow-up visit at any time.
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    K Number
    K083574
    Device Name
    RELIEVA STRATUS MICROFLOW SPACER
    Manufacturer
    ACCLARENT, INC.
    Date Cleared
    2009-01-29

    (57 days)

    Product Code
    KAM
    Regulation Number
    878.4800
    Why did this record match?
    Product Code :

    KAM

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The MicroFlow Spacer (Frontal) is indicated for use as a postoperative spacer to maintain an opening to the frontal sinuses within the first 14 days following surgery. The MicroFlow Spacer also helps to prevent obstruction.
    Device Description
    The Frontal Sinus Spacer is a device that maintains an opening at the frontal sinus for up to 14 days postoperatively. The subject device can be manually removed during an office follow-up visit at any time.
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    K Number
    K072891
    Device Name
    SINUS SPACER
    Manufacturer
    ACCLARENT, INC.
    Date Cleared
    2008-03-19

    (161 days)

    Product Code
    KAM
    Regulation Number
    878.4800
    Why did this record match?
    Product Code :

    KAM

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Sinus Spacer is indicated for use as a postoperative spacer to maintain an opening to the nasal sinuses within the first 14 days following surgery. The Sinus Spacer also helps to prevent obstructions.
    Device Description
    The Sinus Spacer is a device that maintains an opening at the intended sinus not to exceed 14 days postoperatively. The subject device can be manually removed during an office follow-up visit at any time.
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    K Number
    K073041
    Device Name
    RELIEVA AND RELIEVA ACELLA SINUS BALLOON CATHETER
    Manufacturer
    ACCLARENT, INC.
    Date Cleared
    2008-03-11

    (134 days)

    Product Code
    KAM
    Regulation Number
    878.4800
    Why did this record match?
    Product Code :

    KAM

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Relieva Sinus Balloon Catheter is an instrument intended to dilate sinus ostia and spaces within the paranasal sinus cavities for diagnostic and therapeutic procedures. For children aged 17 and under, the balloon catheter system is intended to dilate sinus ostia and spaces associated with the maxillary sinus for diagnostic and therapeutic procedures. Relieva Acella Sinus Balloon Catheter is an instrument intended to dilate sinus ostia and spaces within the paranasal sinus cavities for diagnostic and therapeutic procedures. For children aged 17 and under, the balloon catheter system is intended to dilate sinus ostia and spaces associated with the maxillary sinus for diagnostic and therapeutic procedures.
    Device Description
    The Relieva Sinus Balloon Catheter is a catheter designed to dilate the sinus ostia and paranasal spaces in adults and maxillary sinus spaces in children. The Relieva Acella Sinus Balloon Catheter is a catheter designed to access and to dilate the sinus ostia and paranasal spaces in adults and maxillary sinus spaces in children.
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    K Number
    K071845
    Device Name
    RELIEVA LUMA SINUS ILLUMINATION SYSTEM, MODEL SIS-100A
    Manufacturer
    ACCLARENT, INC.
    Date Cleared
    2007-09-28

    (85 days)

    Product Code
    KAM
    Regulation Number
    878.4800
    Why did this record match?
    Product Code :

    KAM

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Relieva Luma™ Sinus Illumination System is intended to provide a means to access the sinus space for diagnostic and therapeutic procedures in conjunction with other nasal and sinus products. It is also intended to illuminate within and transilluminate across nasal and sinus structures.
    Device Description
    The Relieva Luma™ Sinus Illumination System is a flexible device that transmits light at the distal tip. The system also contains two accessories: a light cable and an adapter.
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    K Number
    K062458
    Device Name
    ETHMOID SINUS SPACER
    Manufacturer
    ACCLARENT, INC.
    Date Cleared
    2006-09-15

    (23 days)

    Product Code
    KAM
    Regulation Number
    878.4800
    Why did this record match?
    Product Code :

    KAM

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Ethmoid Sinus Spacer is indicated for use as a postoperative spacer to maintain an opening to the ethmoid sinus within the first 14 days following surgery. The Ethmoid Sinus Spacer also helps to prevent obstruction.
    Device Description
    Not Found
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    K Number
    K060974
    Device Name
    RELIENT NAVIGATION DEVICE
    Manufacturer
    ACCLARENT, INC.
    Date Cleared
    2006-05-05

    (25 days)

    Product Code
    KAM
    Regulation Number
    878.4800
    Why did this record match?
    Product Code :

    KAM

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Sinus Guide Adapter and Calibration Device are intended to provide a means to access the sinus space for diagnostic and therapeutic procedures.
    Device Description
    The Sinus Guide Adapter is used to hold the Sinus Guide Catheter and the InstaTrak Receiver. The Sinus Guide Adapter is used in conjunction with a Calibration Device that is compatible with the InstaTrak Navigation system. The Calibration Device is used to calibrate the tip position and the trajectory line of the Sinus Guide Catheter. Once calibrated, the Calibration Device is removed.
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    K Number
    K050340
    Device Name
    MICROMEDICS SPHENOID SINUS STENT
    Manufacturer
    MICROMEDICS, INC.
    Date Cleared
    2005-04-27

    (75 days)

    Product Code
    KAM
    Regulation Number
    878.4800
    Why did this record match?
    Product Code :

    KAM

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Intended for use as a postoperative stent to maintain an opening to the sphenoid sinus, during the first 14 days following surgery and helps prevent obstruction by adhesions.
    Device Description
    Sphenoid Sinus Stent
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    K Number
    K994262
    Device Name
    FRONTAL SINUS TREPHINATION CANNULA
    Manufacturer
    XOMED, INC.
    Date Cleared
    2000-02-08

    (53 days)

    Product Code
    KAM, 77K
    Regulation Number
    878.4800
    Why did this record match?
    Product Code :

    KAM

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Frontal Sinus Trephination Cannula is indicated for patients with sinus disease that require frontal sinus irrigation or repeated frontal sinus irrigation for up to thirty days.
    Device Description
    The device consists of a cannula and an occlusion plug.
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