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510(k) Data Aggregation

    K Number
    K220326
    Device Name
    PosiSep X BAM Hemostat Dressing/Intranasal Splint
    Manufacturer
    Hemostasis LLC
    Date Cleared
    2022-11-14

    (283 days)

    Product Code
    EMX, LYA
    Regulation Number
    874.4100
    Why did this record match?
    Product Code :

    EMX

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    PosiSep® X BAM Hemostat Dressing/Intranasal Splint is indicated for use in patients undergoing nasal/sinus surgery as a space occupying hemostat/splint to: - Separate tissue or structures compromised by surgical trauma; - Separate and prevent adhesions between mucosal surfaces during mesothelial cell regeneration in the nasal cavity; - Help control minimal bleeding following surgery or trauma; - Help control minimal bleeding following surgery or nasal trauma by tamponade effect, blood absorption and platelet aggregation; and - Act as an adjunct to aid in the natural healing process PosiSep® X BAM is indicated for use as a nasal hemostat to treat epistaxis. PosiSep® X BAM is intended for use under the direction of a licensed healthcare provider.
    Device Description
    The Hemostasis PosiSep® X BAM is placed in the nasal cavity after sinus surgery to prevent adhesions, control mild bleeding, and provide a level of protection against bacteria and fungi. PosiSep X BAM is supplied as a compressed foam, and it quickly dehydrates blood, thereby causing rapid hemoconcentration of platelets, serum proteins and fibrinogen, leading to clotting that limits and controls bleeding and edema. Upon hydration, PosiSep® X BAM expands to contact and conform to the surrounding anatomy. PosiSep X BAM is comprised of N, O-Carboxymethyl Chitosan derived from non-shell fish based Chitosan, modified Cellulose, and antimicrobial agents. PosiSep® X BAM is fragmentable and eliminated from the site of application by natural excretion through the action of cilia.
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    K Number
    K041446
    Device Name
    NASALCEASE
    Manufacturer
    LES LABORATORIRES BROTHIER, S.A.
    Date Cleared
    2004-07-01

    (30 days)

    Product Code
    EMX
    Regulation Number
    874.4100
    Why did this record match?
    Product Code :

    EMX

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    NasalCEASE™ is intended to be inserted into the anterior nasal cavity to stop minor nosebleeds. It is intended to be marketed and sold as an Over-The-Counter device.
    Device Description
    NasalCEASE™ is comprised of interwoven strands of calcium alginate and is manufactured as a sheet (2x4x0.5 cm) weighing approximately 20mg that can be rolled along its long or short axis and inserted into the anterior nasal cavity.
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    K Number
    K000108
    Device Name
    RAPID RHINO-ANTERIOR 90MM, MODEL RR-A 90, RAPID RHINO-POSTERIOR 100MM, MODEL RR-P 100
    Manufacturer
    BHK HOLDING
    Date Cleared
    2000-05-23

    (130 days)

    Product Code
    EMX
    Regulation Number
    874.4100
    Why did this record match?
    Product Code :

    EMX

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K993362
    Device Name
    HYLASINE
    Manufacturer
    BIOMATRIX, INC.
    Date Cleared
    2000-03-13

    (159 days)

    Product Code
    EMX, 77E
    Regulation Number
    874.4100
    Why did this record match?
    Product Code :

    EMX

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The intended use of Hylasine™ is for use in nasal/sinus cavity as a space-occupying gel stent, to separate mucosal surface and to help control minimal bleeding following surgery or nasal trauma.
    Device Description
    Hylasine™ is a sterile, transparent, viscoelastic gel composed of cross-linked polymers of hyaluronan. Due to its physical properties, Hylasine may be used to reduce synechiae and middle meatal stenosis. Its tamponade effect may also contribute to controlling bleeding. Hylasine leaves the site of placement by natural elimination, or it may be aspirated from the cavity earlier at the discretion of the physician.
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    K Number
    K983276
    Device Name
    HYDROFERA BACTERISTATIC NASAL DRESSING
    Manufacturer
    HYDROFERA, LLC.
    Date Cleared
    1999-09-14

    (362 days)

    Product Code
    EMX
    Regulation Number
    874.4100
    Why did this record match?
    Product Code :

    EMX

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    POST OPERATIVE PACKING AFTER SEPTAL RHINOPLASTIC, OR TURBINATE SURGERY.
    Device Description
    BACTERISTATIC NASAL DRESSING
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    K Number
    K982731
    Device Name
    MEROGEL NASAL DRESSING AND SINUS STENT
    Manufacturer
    XOMED, INC.
    Date Cleared
    1999-02-02

    (181 days)

    Product Code
    EMX
    Regulation Number
    874.4100
    Why did this record match?
    Product Code :

    EMX

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Xomed MeroGel™ Nasal Dressing and Sinus Stent is intended for use in the nasal/sinus cavities as a space-occupying dressing and/or stent, to separate mucosal surfaces and to help control minimal bleeding following surgery.
    Device Description
    Xomed MeroGel™ Nasal Dressing and Sinus Stent is a biomaterial composed of HYAFF®, an ester of hyaluronic acid, a natural occurring constituent of the extracellular matrix. Due to its absorption properties, MeroGel™ may be used to help control minimal bleeding. In contact with body fluids, it changes into viscous and transparent gel, conforming to mucosal surfaces and eventually dissolves or may be irrigated from the cavity.
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    K Number
    K984069
    Device Name
    ENTAXIS NASAL PACKING
    Manufacturer
    LES LABORATORIRES BROTHIER, S.A.
    Date Cleared
    1999-01-25

    (70 days)

    Product Code
    EMX
    Regulation Number
    874.4100
    Why did this record match?
    Product Code :

    EMX

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    ENTaxis™ Nasal Packing is intended for - Epistaxis - Post operative nasal packing
    Device Description
    ENTaxis™ Nasal Packings are highly conformable, sterile, hemostatic packings designed for managing bleeding in the nasal cavity and as post operative packings. ENTaxis™ nasal packings are 12" (30cm, 2g) "ropes" that are 100% composed of pure calcium alginate fibers.
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    K Number
    K981966
    Device Name
    NOSEBLEED NOSECLIP
    Manufacturer
    MICHAEL M. KNOTT, M.D.
    Date Cleared
    1998-08-14

    (71 days)

    Product Code
    EMX
    Regulation Number
    874.4100
    Why did this record match?
    Product Code :

    EMX

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The treatment of simple anterior (front) nosebleeds by application of a noseclip to the external nose in adults and children. Not for use on infants.
    Device Description
    Existing respiratory noseclip is to be used to treat simple anterior (front) nosebleeds.
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    K Number
    K973085
    Device Name
    ULTRACELL PACKING WITH SLEEVE
    Manufacturer
    ULTRACELL MEDICAL TECHNOLOGIES, INC.
    Date Cleared
    1997-11-18

    (92 days)

    Product Code
    EMX
    Regulation Number
    874.4100
    Why did this record match?
    Product Code :

    EMX

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The device is used during surgery to protect tissue from trauma, absorb fluids and to act as a barrier against adhesions.
    Device Description
    Not Found
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    K Number
    K973656
    Device Name
    DISPOSABLE SILICONE EPISTAXIS CATHETER
    Manufacturer
    SPECIALTY SURGICAL PRODUCTS, INC.
    Date Cleared
    1997-11-18

    (54 days)

    Product Code
    EMX
    Regulation Number
    874.4100
    Why did this record match?
    Product Code :

    EMX

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The catheter is designed to aid in controlling nasal hemorrhage due to trauma from injury. The device may r he baneler is a postoperative nasal packing following various intranasal surgical procedures, including septoplasty and rhinoplasty procedures.
    Device Description
    Disposable Sillicone Epistaxis Catheter
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