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510(k) Data Aggregation

    K Number
    K193346
    Device Name
    Codman Surgical Patties & Strips
    Manufacturer
    Integra LifeSciences Corporation
    Date Cleared
    2020-11-20

    (353 days)

    Product Code
    HBA
    Regulation Number
    882.4700
    Why did this record match?
    Product Code :

    HBA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The surgical patties and surgical strips are indicated for the use including brain and other tissues of the central nervous system, during surgery.
    Device Description
    The Codman Surgical Patties and Strips are single use, sterile devices indicated for the use in protection of tissue, including brain and other tissues of the central nervous system, during surgery. The Surgical Patties are comprised of 3 main components: Cottonoid Material, String and X-ray detectable monofilament. The Strips are comprised of 2 main parts: Cottonoid Material and X-ray detectable monofilament.
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    K Number
    K140369
    Device Name
    MEDLINE NEURO SPONGE
    Manufacturer
    MEDLINE INDUSTRIES, INC.
    Date Cleared
    2014-09-26

    (224 days)

    Product Code
    HBA
    Regulation Number
    882.4700
    Why did this record match?
    Product Code :

    HBA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The device is intended to be used by trained physicians in neurosurgical procedures to protect nervous tissue, absorb fluids and stop bleeding.
    Device Description
    Not Found
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    K Number
    K112598
    Device Name
    AMERICAN SURGICAL COMPANY/ NEUROSURGICAL SPONGES (BRAND)
    Manufacturer
    AMERICAN SURGICAL COMPANY, LLC
    Date Cleared
    2013-06-20

    (652 days)

    Product Code
    HBA
    Regulation Number
    882.4700
    Why did this record match?
    Product Code :

    HBA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The device is intended to be used by trained physicians during neurosurgical procedures to protect neural tissues from drying, abrasion, or contamination and to absorb fluids. The device is indicated for use by trained physicians during neurosurgical procedures to protect neural tissues from drying, abrasion, or contamination and to absorb fluids:
    Device Description
    The device is a non-adherent, strung, x-ray detectable surgical sponge that is sterile and disposable. The American Surgical Sponges (brand) product line is made from cotton, polyester, or rayon in various sizes and shapes and has been first marketed since 1985. The current cleared product line includes the Telfa® Sponges, which are cotton surgical sponges covered on both sides with polyethylene terephthalate. The Telfa® Sponges provide additional stiffness to the neurosurgical sponges. The new proposed addition to the product line includes neurosurgical sponges (cotton, polyester, or rayon) covered on one side with a thin single layer of polytetrafluoroethylene (PTFE) to enhance the material stiffness and non-adherence properties while maintaining flexibility of the sponge. The polytetrafluoroethylene (PTFE) layer will be provided in a choice of three thicknesses, 0.001", 0.003" or 0.005". The sponges range in size from 6mm × 76mm × 76mm.
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    K Number
    K121822
    Device Name
    DELICOT
    Manufacturer
    AMERICAN SURGICAL COMPANY, LLC
    Date Cleared
    2012-09-10

    (81 days)

    Product Code
    HBA
    Regulation Number
    882.4700
    Why did this record match?
    Product Code :

    HBA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The device is a neurosurgical pad used during surgery to protect nervous tissue, absorb fluids, or stop bleeding.
    Device Description
    The device is a non-adherent, strung, x-ray detectable surgical sponge that is sterile and disposable. The Delicot product line is made from lyocell, a manmade fiber derived from cellulose, better known under the brand name of Tencel - a type of rayon; it is supplied in various lengths and widths and has been marketed since 1990. The Delicot product line is one of three rayon-based sponges. The Delicot sponges are manufactured using Dupont Style 8623 consisting of 100% lyocell. Dupont has discontinued the manufacture of Style 8623. Dupont Style 8471 consisting of 58% polyester and 42% lyocell is our proposed replacement.
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    K Number
    K073576
    Device Name
    NEUROSURGICAL SPONGES AND PADDLES AND NEURO PATTIES AND NEUROSPONGES
    Manufacturer
    HAROD ENTERPRISES, INC.
    Date Cleared
    2008-02-22

    (65 days)

    Product Code
    HBA
    Regulation Number
    882.4700
    Why did this record match?
    Product Code :

    HBA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The neurological sponge is a cotton or rayon pattie used to keep exposed tissue from drying out during surgery. It is used to absorb excess fluids and to protect the tissue from trauma during surgery. It is also used to assist in the gentle suction of fluids.
    Device Description
    Neurosurgical Paddies are used to keep exposed tissue from drying out or to absorb excess fluids and to protect the tissue from trauma during surgery. They are manufactured from either cotton or viscose fibers cut into rectangular pads of various sizes with a suture string attached for ease in count verification and with an x-ray detectable marker sewn to it as an extra precaution. The paddies are normally packaged 10 per count card of a single size and may be sterilized for end use or sold non sterile for kit packers. They are single use items that can be ETO sterilized twice or E-beam sterilized once. HE, Inc.'s product will be made from cotton and/or or rayon in sizes and shapes similar to the predicate devices as they have been since 2005 under a 510(k) license. The most commonly used sizes are ½' x ½', ½' x 1", ½" x 3", 1" x 1" and 1" x 3".
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    K Number
    K062406
    Device Name
    AESCULAP NEURO PATTIES
    Manufacturer
    AESCULAP, INC.
    Date Cleared
    2006-09-15

    (29 days)

    Product Code
    HBA
    Regulation Number
    882.4700
    Why did this record match?
    Product Code :

    HBA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Aesculap's Neuro Patties are intended for use during surgery to protect nervous tissue, absorb fluids, or stop bleeding during neurological and other general procedures.
    Device Description
    Aesculap's Neuro Patties are rectanqular fluid absorption pads for use during neurological and/or general procedures. The devices are available in a variety of dimensions and sizes. The neuro patties are manufactured from either a cotton or viscose fibers. All patties have a suture string attached for ease in count verification, they are also available with x-ray detectable markers if desired. The patties are packaged 10 per card in either single size sets or in procedure (indication) sets with a variety of sizes. These devices are provided sterile or non-sterile (for kit packager), single use only, and should not be resterilized.
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    K Number
    K031008
    Device Name
    AESCULAP NEURO PATTIES, NEUROSORB 4, 6, AND 75 (GREEN & WHITE)
    Manufacturer
    AESCULAP
    Date Cleared
    2003-05-09

    (39 days)

    Product Code
    HBA
    Regulation Number
    882.4700
    Why did this record match?
    Product Code :

    HBA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Aesculap's Neuro Patties are intended for use during surgery to protect nervous tissue, absorb fluids, or stop bleeding during neurological and other general procedures.
    Device Description
    Aesculap's Neuro Patties are rectangular fluid absorption pads for use during neurological and/or general procedures. The devices are available in a variety of dimensions, with widths from 4mm to 70mm and lengths from 6mm to 150mm. The material used for the patties is natural woven cotton fiber, this material is available in either a tight weave (neurosorb 4 or 6) or a more open gauze-like weave (neurosorb 75). The neurosorb 4 material consists of 4 layers while neurosorb 6 is constructed with 6 layers, the layers provide different levels of absorbency for surgeon preference. All pattles have a suture string attached for ease in count verification, they are also available with x-ray detectable markers if desired. The patties are packaged 10 per card in either single size sets or in procedure (indication) sets with a variety of sizes. These devices are for single use only and should not be resterilized.
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    K Number
    K020736
    Device Name
    TRAATEK COTTONOID PATTIES
    Manufacturer
    TRAATEK, INC.
    Date Cleared
    2002-06-03

    (89 days)

    Product Code
    HBA
    Regulation Number
    882.4700
    Why did this record match?
    Product Code :

    HBA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    To be used in surgery to protect nervous tissue, absorb fluids, or stop bleeding.
    Device Description
    Not Found
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    K Number
    K014268
    Device Name
    NORAPAD PLAIN; NORAPAD TA
    Manufacturer
    PERLEI MEDICAL, INC.
    Date Cleared
    2002-03-27

    (90 days)

    Product Code
    HBA
    Regulation Number
    882.4700
    Why did this record match?
    Product Code :

    HBA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Intended for neurosurgical procedures to protect tissue, absorb fluids and stop bleeding. They are Supplied to the user in sterile packages. These patties are X-ray detectable and are provided in a variety of sizes necessary to meet clinical needs.
    Device Description
    Not Found
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    K Number
    K993019
    Device Name
    PACIFIC SURGICAL PATTIES
    Manufacturer
    V. MUELLER NEURO/SPINE
    Date Cleared
    2000-03-30

    (204 days)

    Product Code
    HBA
    Regulation Number
    882.4700
    Why did this record match?
    Product Code :

    HBA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    To be used in surgery to protect nervous tissue, absorb fluids, or stop bleeding.
    Device Description
    A cotton pad used during surgery to protect nervous tissue, absorb fluids or stop bleeding.
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