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510(k) Data Aggregation

    K Number
    K130354
    Device Name
    MEDIENT MIDDLE TURBINATE IMPLANT; (SINGLE PACK-1 PAIR, FOUR PACK-4 PAIR)
    Manufacturer
    ENTRIGUE SURGICAL, INC.
    Date Cleared
    2013-05-29

    (106 days)

    Product Code
    LYA
    Regulation Number
    874.4780
    Why did this record match?
    Applicant Name (Manufacturer) :

    ENTRIGUE SURGICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The MediENT® Middle Turbinate Implant is intended to separate the middle turbinate from the lateral nasal wall during the clinically relevant healing phase associated with nasal/sinus surgery. The implant provides short-term fixation of the middle turbinate to the nasal septum and thus minimizes the risk of adherence to the lateral nasal wall.
    Device Description
    The MediENT® Middle Turbinate Implant is a tack made of an absorbable copolymer that is designed to hold the middle turbinate away from the lateral nasal wall. The sterile, single-use implant is delivered using standard surqical instruments, such as Alligator grasper, Pediatric Blakesly, MediENT® Grasper or similar. The implant provides temporary fixation and can be expected to start degrading approximately 2 to 3 months post-implantation. The MediENT® Middle Turbinate Implant is packaged and provided sterile for single use only.
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    K Number
    K121351
    Device Name
    SINUS DILATION SYSTEM
    Manufacturer
    ENTRIGUE SURGICAL, INC.
    Date Cleared
    2012-08-29

    (117 days)

    Product Code
    LRC
    Regulation Number
    874.4420
    Why did this record match?
    Applicant Name (Manufacturer) :

    ENTRIGUE SURGICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ENTrigue® Sinus Dilation System is intended for use in surgical procedures to access, examine or treat the nasal and paranasal tissues leading to ostia. The ENTrigue® Sinus Dilation System is indicated to access and treat the frontal recesses, sphenoid sinus ostia, and maxillary ostia/ethmoid infundibula in adults using a trans-nasal approach.
    Device Description
    The ENTrigue® Sinus Dilation System consists of a disposable balloon which is mounted on a reusable delivery instrument to allow for dilation of sinus ostia in the paranasal cavity under endoscopic quidance. The Sinus Balloon components include a balloon sleeve to slide over the tip of the delivery instrument, a connecting collar to latch the balloon sleeve to the delivery instrument, and an inflation line to connect to the balloon inflation device. The features of this device enable a physician to quide the device to the sinus ostium using endoscopic visualization. The ENTrigue® Sinus Balloon Dilation Balloon and inflation device are individually packaged and provided sterile for single use only. The delivery instrument is a reusable instrument which must be sterilized prior to use following the recommended and validated cleaning and sterilizing procedures.
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    K Number
    K082750
    Device Name
    ENTACT SEPTAL STAPLER, MODEL 610-00100
    Manufacturer
    ENTRIGUE SURGICAL, INC.
    Date Cleared
    2009-01-06

    (109 days)

    Product Code
    OLL
    Regulation Number
    878.4750
    Why did this record match?
    Applicant Name (Manufacturer) :

    ENTRIGUE SURGICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ENTact™ Septal Stapler delivers implantable septal staples which are intended to connect internal tissues to aid healing and for approximation of soft tissues during nasal septal surgery.
    Device Description
    The ENTact™ Septal Stapler consists of resorbable fixation devices, which are delivered via an manual surgical stapler delivery system. The ENTact™ implantable septal staples, composed of an absorbable copolymer, may be used during nasal surgery to approximate the mucoperichondrial flaps of the nasal septum and at the completion of surgery. The staples are provided preloaded in a single-use, disposable stapler.
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    K Number
    K072470
    Device Name
    BIOELAST 5-0 SUTURE, MODEL 500100
    Manufacturer
    ENTRIGUE SURGICAL, INC.
    Date Cleared
    2007-11-16

    (73 days)

    Product Code
    NWJ
    Regulation Number
    878.4494
    Why did this record match?
    Applicant Name (Manufacturer) :

    ENTRIGUE SURGICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    BioElast™ 5-0 absorbable sutures are indicated for use in general soft tissue approximation and/or ligation, but not for use in cardiovascular or neurological tissues, microsurgery or ophthalmic surgery.
    Device Description
    BioElast™ 5-0 Suture is a sterile, monofilament, absorbable surgical suture composed of poly-4-hydroxybutyrate. The BioElast™ 5-0 Sutures will be provided undyed at a 5-0 size.
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