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510(k) Data Aggregation

    K Number
    K150032
    Device Name
    GluStitch Twist Tissue Adhesive
    Manufacturer
    Date Cleared
    2016-01-14

    (371 days)

    Product Code
    Regulation Number
    878.4010
    Why did this record match?
    Applicant Name (Manufacturer) :

    GLUSTITCH, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    GluStitch® Twist Tissue Adhesive is intended for the topical skin incisions and trauma-induced lacerations in areas of low skin tension that are simple, thoroughly-cleansed, and have easily approximated skin edges. GluStitch® Twist may be used in conjunction with, but not in place of, deep dermal stitches.
    Device Description
    GluStitch Twist Tissue Adhesive is a sterile, topical tissue adhesive containing n-butyl-2-cyanoacrylate. GluStitch Twist Tissue Adhesive is supplied in a single patient use, twist-and-use ampoule that contains at least 0.5g of liquid tissue adhesive.
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    K Number
    K083752
    Device Name
    GLUSEAL 90, MODEL GLU9010
    Manufacturer
    Date Cleared
    2009-02-23

    (68 days)

    Product Code
    Regulation Number
    880.5090
    Why did this record match?
    Applicant Name (Manufacturer) :

    GLUSTITCH, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    GluSeal® 90 liquid adhesive bandage is intended to cover minor cuts, scrapes, burns, and minor irritations of the skin and help protect them from infection.
    Device Description
    The GluSeal® 90 is a formulated compound of the cyanoacrylate series. The compound, which exists in monomeric form in the plastic containers, polymerizes extremely rapidly in the presence of anions, especially of hydroxyl ions [in the presence of water]. It has the ability to adhere to moist living tissues. It demonstrates a favorable tissue response and reveals no toxic or foreign body reaction in humans.
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    K Number
    K071484
    Device Name
    PERIACRYL 90,80,70,60, MODEL9010, 8020, 7030, 6040
    Manufacturer
    Date Cleared
    2007-10-10

    (133 days)

    Product Code
    Regulation Number
    872.3275
    Why did this record match?
    Applicant Name (Manufacturer) :

    GLUSTITCH, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    PeriAcryl® 90, PeriAcry18 80, PeriAcry1 70, and PeriAcry16 60 are indicated to be used as an adjunct to temporarily assist in securing periodontal dressings.
    Device Description
    The Family of PeriAcryl® is a formulated compound of the cyanoacrylate series. It is available in 90/10 butyl/octyl, 80/20, butyl/octyl, 70/30 butyl/octyl and 60/40 butyl/octyl formulations depending on the dentist's preference. The compound, which exists in monomeric form in the plastic containers, polymerizes extremely rapidly in the presence of anions, especially of hydroxyl ions [in the presence of water]. It has the ability to adhere to moist living tissues. It demonstrates a favorable tissue response and reveals no toxic or foreign body reaction in humans.
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    K Number
    K030574
    Device Name
    GLUSEAL 5ML DISPENSER, 1 ML DISPENSER, .2 ML DISPENSER
    Manufacturer
    Date Cleared
    2003-08-21

    (178 days)

    Product Code
    Regulation Number
    880.5090
    Why did this record match?
    Applicant Name (Manufacturer) :

    GLUSTITCH, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    GluSeal™ liquid adhesive bandage is intended to cover minor cuts, scrapes, burns, and minor irritations of the skin and help protect them from infection.
    Device Description
    GluSeal™ is monomeric 2 octyl cyanoacrylate. This compound, which exists in monomeric form in the plastic containers, polymerizes extremely rapidly in the presence of anions, especially of hydroxyl ions (in the presence of water). GluSeal™ will be packaged in three different ways ranging from a multiuse bottle containing 5 ml cyanoacrylate; a multiuse vial containing 1 ml cyanoacrylate, and a kit containing 12 x 0.2 ml disposable applicators. Each of the multiuse kits will contain application pipettes and administration dishes or administration trays.
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    K Number
    K013446
    Device Name
    GLUSITE, MODEL GLU002
    Manufacturer
    Date Cleared
    2001-12-20

    (64 days)

    Product Code
    Regulation Number
    872.3275
    Why did this record match?
    Applicant Name (Manufacturer) :

    GLUSTITCH, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    GluSite is indicated for use as dental cement for bonding dental materials such as crowns, caps, and pins, or temporarily attaching a fiber to the surface of the tooth in a procedure to treat periodontal disease.
    Device Description
    GluSite (2-octyl cynoacrylate) is a clear colorless, free-flowing liquid monomer packaged in a glass multiple-use vials. Upon contact with weak bases, GluSite polymerizes to form a strong adhesive bond. Depending on the availability of moisture, this could take up to one minute.
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