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510(k) Data Aggregation

    K Number
    K163247
    Device Name
    3.3 mm Laurimed Microdebrider; 4.0 mm Laurimed Microdebrider
    Manufacturer
    Date Cleared
    2017-03-09

    (111 days)

    Product Code
    Regulation Number
    874.4250
    Why did this record match?
    Applicant Name (Manufacturer) :

    LAURIMED LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The PolypVac Microdebrider is a shaver system intended for the resection of soft tissue and thin bone as part of the following endoscopic sinus procedures: ethmoidectomy, maxillary antrostomy, polypectomy, turbinectomy / turbinate reduction, sphenoidotomy, and frontal recess dissection.
    Device Description
    The PolypVac Microdebrider is a shaver system intended for the resection of soft tissue and thin bone as part of endoscopic sinus procedures. The system consists of a hand-held cutting device, tissue filter, and stylet. The PolypVac Microdebrider is supplied sterile and is single-use and disposable.
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    K Number
    K161101
    Device Name
    PolypVac Microdebrider (3.3mm and 4.0mm)
    Manufacturer
    Date Cleared
    2016-06-22

    (64 days)

    Product Code
    Regulation Number
    874.4250
    Why did this record match?
    Applicant Name (Manufacturer) :

    LAURIMED LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Indicated for the excision of polyps in the nasal passageways and in sinuses for which access has been previously established.
    Device Description
    The Laurimed PolypVac Microdebrider is intended for cutting and aspirating polyp tissue during sinus and nasal procedures. The system consists of a hand-held cutting device, tissue filter, and stylet. The PolypVac Microdebrider is supplied sterile and is single-use and disposable.
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    K Number
    K133133
    Device Name
    LAURIMED POLYPVAC MICRODEBRIDER
    Manufacturer
    Date Cleared
    2013-12-23

    (84 days)

    Product Code
    Regulation Number
    874.4250
    Why did this record match?
    Applicant Name (Manufacturer) :

    LAURIMED LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Indicated for the excision of polyps in the nasal passageways and in sinuses for which access has has been previously established.
    Device Description
    The Laurimed PolypVac Microdebrider is intended for cutting and aspirating polyp tissue during sinus and nasal procedures. The system consists of a hand-held cutting device and device cleaner. The PolypVac Microdebrider is supplied sterile and is single-use and disposable.
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    K Number
    K091818
    Device Name
    LAURIMED SPINAL INJECTION SYSTEM
    Manufacturer
    Date Cleared
    2009-09-23

    (97 days)

    Product Code
    Regulation Number
    868.5150
    Why did this record match?
    Applicant Name (Manufacturer) :

    LAURIMED LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The TruCath Spinal Injection System is indicated for use in injections into the epidural space. Not for use with other catheters or needles.
    Device Description
    The Trucath Spinal Injection System integrates a flexible Catheter with an atraumatic distal tip into a Needle designed for use in injections into the epidural space of the spine. The Trucath Spinal Injection System is supplied as a sterile, single patient use, disposable device.
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    K Number
    K090815
    Device Name
    PERCUTANEOUS DISCECTOMY SYSTEM
    Manufacturer
    Date Cleared
    2009-05-21

    (57 days)

    Product Code
    Regulation Number
    888.1100
    Why did this record match?
    Applicant Name (Manufacturer) :

    LAURIMED LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Laurimed Discectomy System is indicated for use in aspiration of disc material during open discectomies in the lumbar region of the spine.
    Device Description
    The Laurimed Discectomy System is intended to be used to cut and aspirate nucleus material from discs in the spine. The system consists of a set of introduction tools (Dilator, Straight Cannula, Curved Cannula (qty. 2) and Trocar), a Device Cleaner, and a Discectomy Device The Laurimed Discectomy System is supplied as a sterile, single patient use, single-level, disposable device.
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    K Number
    K083909
    Device Name
    SPINAL INJECTION SYSTEM
    Manufacturer
    Date Cleared
    2009-03-18

    (78 days)

    Product Code
    Regulation Number
    868.5150
    Why did this record match?
    Applicant Name (Manufacturer) :

    LAURIMED LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Laurimed Spinal Injection System is intended for use in procedures where injection is required. The Laurimed Spinal Injection System is indicated for use in spinal epidural iniections for the administration of contrast media, anesthetic agents to provide regional anesthesia, and anti-inflammatory medications. Not for use with other needles or catheters.
    Device Description
    The Laurimed Spinal Injection System integrates a flexible Catheter with an atraumatic distal tip into a Needle designed for injections/infusions of contrast media, anesthetics, and anti-inflammatory medications into the epidural space of the spine. The Spinal Injection System is supplied as a sterile, single patient use, disposable device.
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    K Number
    K082194
    Device Name
    LAURIMED PERCUTANEOUS DISCECTOMY SYSTEM, MODEL FG-000002
    Manufacturer
    Date Cleared
    2008-08-28

    (24 days)

    Product Code
    Regulation Number
    888.1100
    Why did this record match?
    Applicant Name (Manufacturer) :

    LAURIMED LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Laurimed Percutaneous Discectomy System is indicated for use in aspiration of disc material during percutaneous discectomies in the lumbar region of the spine.
    Device Description
    The Laurimed Percutaneous Discectomy System is intended to be used to cut and aspirate nucleus material from discs in the spine. The system consists of a set of introduction tools (Introducer Needle with Stylet, Guidewire, Dilator, Cannula, Trocar, and Cannula Clamp), a Device Cleaner, and a Discectomy Device. The Laurimed Percutaneous Discectomy System is supplied as a sterile, single patient use, single-level, disposable device.
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    K Number
    K080140
    Device Name
    LAURIMED SPINAL INJECTION SYSTEM
    Manufacturer
    Date Cleared
    2008-05-09

    (108 days)

    Product Code
    Regulation Number
    868.5150
    Why did this record match?
    Applicant Name (Manufacturer) :

    LAURIMED LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Laurimed Spinal Injection System is intended for use in procedures where injection is required. The Laurimed Spinal Injection System is indicated for use in spinal epidural injections for administration of anesthetic agents to provide regional anesthesia. Not for use with other needles or catheters.
    Device Description
    The Laurimed Spinal Injection System integrates a flexible Catheter with an atraumatic distal tip into a Needle designed for injections/infusion of local anesthetics into the epidural space of the spine. The Spinal Injection System is supplied as a sterile, single patient use, disposable device.
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