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510(k) Data Aggregation

    K Number
    K223669
    Device Name
    SecurePortIV Advanced Catheter Securement Adhesive
    Manufacturer
    Adhezion Biomedical, LLC.
    Date Cleared
    2023-06-12

    (187 days)

    Product Code
    NZP
    Regulation Number
    878.4370
    Why did this record match?
    Applicant Name (Manufacturer) :

    Adhezion Biomedical, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    SECUREPORTIV® ADVANCED Catheter Securement Adhesive is to be applied as a film forming securement and sealant at the point of vascular access catheter skin entry. The film holds the catheter to the skin to reduce catheter movement, migration, and/or dislodgment. It is used to protect the catheter skin entry site by creating a sealant that immobilizes surface bacteria, preventing them from entering into the catheter skin entry site while a moisture barrier. SECUREPORTIV® ADVANCED is intended to be used with a transparent film dressing for the securement of short-term and long-term vascular access catheters including peripheral IVs, PICCs, and CVCs.
    Device Description
    SecurePortIV Advanced Catheter Adhesive is a sterile, professional liquid cyanoacrylatebased adhesive containing a monomeric formulation (2-octyl cyanoacrylate) and the colorant D&C Violet #2. The device is an applicator with the formulation incorporated in an ampoule housed in a tapered plastic tube. The SecurePortIV Advanced liquid is applied as a film forming securement and sealant at the point of catheter skin entry, polymerizing in minutes.
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    K Number
    K170505
    Device Name
    SecurePortIV Catheter Securement Adhesive
    Manufacturer
    Adhezion Biomedical, LLC
    Date Cleared
    2017-09-29

    (220 days)

    Product Code
    NZP
    Regulation Number
    878.4370
    Why did this record match?
    Applicant Name (Manufacturer) :

    Adhezion Biomedical, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    SecurePortIV™ catheter securement adhesive is to be applied as a film forming securement and sealant at the point of vascular access catheter skin entry. The film holds the catheter to the skin to reduce catheter movement, migration, and/or dislodgment. It is used to protect the catheter skin entry site by creating a sealant that immobilizes surface bacteria, preventing them from entering into the catheter skin entry site while also providing a moisture barrier. SecurePortV™ is intended to be used with a transparent film dressing on short-term and long-term vascular access catheters including peripheral IVs, PICCs, and CVCs.
    Device Description
    SecurePortIV Catheter Adhesive is a sterile, professional liquid cyanoacrylate-based adhesive containing a two monomeric formulation (2-octyl cyanoacrylate and butyl cyanoacrylate) and the colorant D&C Violet #2. The device is an applicator with the formulation incorporated in an ampoule housed in a tapered plastic tube. The SecurePortIV liquid is applied as a film forming securement and sealant at the point of catheter skin entry, polymerizing in minutes. It is intended to be used in conjunction with a transparent film dressing.
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    K Number
    K161011
    Device Name
    SURGISEAL Topical Skin Adhesive, SURGISEAL Stylus Topical Skin Adhesive, SURGISEAL Twist Topical Skin Adhesive
    Manufacturer
    Adhezion Biomedical, LLC
    Date Cleared
    2016-11-08

    (211 days)

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

    Adhezion Biomedical, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    SURGISEAL Topical Skin Adhesive is intended for topical applications only to hold closed easily approximated skin edges of wounds from surgical incisions, including punctures from minimally invasive surgery, simple, thoroughly cleansed, trauma induced lacerations. SURGISEAL may be used in conjunction with, but not in place of, deep dermal sutures
    Device Description
    SURGISEAL® Topical Skin Adhesive is a sterile, professional liquid skin adhesive containing a monomeric (2-octyl cyanoacrylate) formulation and the colorant D&C Violet #2. It incorporates the Teardrop applicator that consists of a thermoformed blister tray with a heat sealed lid with an attached applicator sponge tip. The Stylus and Twist applicators contain the identical adhesive formula and incorporate a plastic ampoule, which houses the adhesive, contained within the double longer plastic sleeves with an attached applicator tip. When SURGISEAL is applied to the skin with these applicators, it polymerizes in minutes.
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    K Number
    K150866
    Device Name
    SURGISEAL Topical Skin Adhesvie
    Manufacturer
    ADHEZION BIOMEDICAL, LLC
    Date Cleared
    2015-07-17

    (107 days)

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

    ADHEZION BIOMEDICAL, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    SURGISEAL Topical Skin Adhesive is intended for topical applications only to hold closed easily approximated skin edges of wounds from surgical incisions, including punctures from minimally invasive surgery, simple, thoroughly cleansed, trauma induced lacerations. SURGISEAL may be used in conjunction with, but not in place of, deep dermal sutures.
    Device Description
    Adhesive containing a monomeric (2-octyl cyanoacrylate) formulation and the colorant D&C Violet #2. It incorporates the Teardrop applicator that consists of a thermoformed blister tray with a heat sealed lid with an attached applicator sponge tip. When SURGISEAL is applied to the skin with the applicator, it polymerizes in minutes.
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    K Number
    K133963
    Device Name
    SURGISEAL TWIST (TM) TOPICAL SKIN ADHESIVE
    Manufacturer
    Adhezion Biomedical, LLC
    Date Cleared
    2014-09-09

    (259 days)

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

    Adhezion Biomedical, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    SURGISEAL Topical Skin Adhesive is intended for topical applications only to hold closed easily approximated skin edges of wounds from surgical incisions, including punctures from minimally invasive surgery, simple, thoroughly cleansed, trauma induced lacerations. SURGISEAL may be used in conjunction with, but not in place of, deep dermal sutures
    Device Description
    SURGISEAL Twist Topical Skin Adhesives are sterile, professional liquid topical skin adhesives containing a monomeric (2-octyl cyanoacrylate) formulation and the colorant D & C Violet #2. Each applicator is comprised of a plastic ampoule container contained within an applicator sleeve with the applicator tip. This Twist applicator tray is contained in an outer Tyvek pouch. When SURGISEAL is applied to the skin, it polymerizes in minutes. In vitro studies have shown that SURGISEAL acts as a physical barrier to microbial penetration as long as the adhesive film remains intact. Clinical studies were not conducted to demonstrate microbial barrier properties and a correlation between microbial barrier properties and a reduction in infection have not been established.
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    K Number
    K141215
    Device Name
    SURGISEAL TWIST TOPICAL SKIN ADHESIVE
    Manufacturer
    Adhezion Biomedical, LLC
    Date Cleared
    2014-08-21

    (101 days)

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

    Adhezion Biomedical, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    SURGISEAL Topical Skin Adhesive is intended for topical applications only to hold closed easily approximated skin edges of wounds from surgical incisions, including punctures from minimally invasive surgery, simple, thoroughly cleansed, trauma induced lacerations. SURGISEAL may be used in conjunction with, but not in place of, deep dermal sutures.
    Device Description
    SURGISEAL® Topical Skin Adhesive is a sterile, professional liquid skin adhesive containing a monomeric (2-octyl cyanoacrylate) formulation and the colorant D&C Violet #2. The SURGISEAL Twist applicator contains the identical adhesive formula as the predicate devices, SURGISEAL® Topical Skin Adhesive and SURGISEAL StylusTM Topical Skin Adhesive, but is comprised of a plastic ampoule container contained within an applicator sleeve with the applicator tip. This Twist applicator tray is contained in an outer Tyvek pouch. When SURGISEAL is applied to the skin with either Applicator, it polymerizes in minutes. In vitro studies have shown that SURGISEAL acts as a physical barrier to microbial penetration as long as the adhesive film remains intact. Clinical studies were not conducted to demonstrate microbial barrier properties and a correlation between microbial barrier properties and a reduction in infection have not been established.
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    K Number
    K140517
    Device Name
    SURGISEAL TOPICAL SKIN ADHESIVE/SURGISEAL STYLUS TOPICAL SKIN ADHESIVE
    Manufacturer
    Adhezion Biomedical, LLC
    Date Cleared
    2014-04-28

    (59 days)

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

    Adhezion Biomedical, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    SURGISEAL Topical Skin Adhesive is intended for topical applications only to hold closed easily approximated skin edges of wounds from surgical incisions, including punctures from minimally invasive surgery, simple, thoroughly cleansed, trauma induced lacerations. SURGISEAL may be used in conjunction with, but not in place of, deep dermal sutures.
    Device Description
    SURGISEAL® Topical Skin Adhesive is a sterile, professional liquid skin adhesive containing a monomeric (2-octyl cyanoacrylate) formulation and the colorant D&C Violet #2. It incorporates the Teardrop applicator that consists of a thermoformed blister tray with a heat sealed lid with an attached applicator sponge tip. The Stylus applicator incorporates the identical adhesive formula but incorporates the Stylus applicator that consists of a plastic ampoule, which houses the adhesive, contained with the longer plastic sleeve within a longer plastic sleeve with an attached applicator tip. When SURGISEAL is applied to the skin with either Applicator, it polymerizes in minutes. In vitro studies have shown that SURGISEAL acts as a physical barrier to microbial penetration as long as the adhesive film remains intact. Clinical studies were not conducted to demonstrate microbial barrier properties and a correlation between microbial barrier properties and a reduction in infection have not been established.
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    K Number
    K130329
    Device Name
    SURGISEAL TOPICAL SKIN ADHESIVE
    Manufacturer
    Adhezion Biomedical, LLC
    Date Cleared
    2013-12-03

    (295 days)

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

    Adhezion Biomedical, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    SURGISEAL Topical Skin Adhesive is Intended for topical applications only to hold closed easily approximated skin edges of wounds from surgical incisions, including punctures from minimally invasive surgery, simple, thoroughly cleansed, trauma induced lacerations. SURGISEAL may be used in conjunction with, but not in place of, deep dermal sutures.
    Device Description
    SURGISEAL® Topical Skin Adhesive is a sterile, professional liquid skin adhesive containing a monomeric (2-octyl cyanoacrylate) formulation and the colorant D&C Violet #2. Each applicator consists of a thermoformed blister tray with a heat sealed lid with an attached applicator sponge tip. This applicator tray with sponge tip is contained in an outer Tyvek pouch. When SURGISEAL is applied to the skin, it polymerizes in minutes.
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    K Number
    K130474
    Device Name
    SURGISEAL TOPICAL SKIN ADHESIVE
    Manufacturer
    Adhezion Biomedical, LLC
    Date Cleared
    2013-05-31

    (95 days)

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

    Adhezion Biomedical, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    SURGISEAL Topical Skin Adhesive is intended for topical applications only to hold closed easily approximated skin edges of wounds from surgical incisions, including punctures from minimally invasive surgery, simple, thoroughly cleansed, trauma induced lacerations. SURGISEAL may be used in conjunction with, but not in place of, deep dermal sutures.
    Device Description
    SURGISEAL Stylus and Stylus Twist Topical Skin Adhesive are sterile, professional liquid topical skin adhesives containing a monomeric (2-octyl cyanoacrylate) formulation and the colorant D & C Violet #2. Each applicator is comprised of a plastic ampoule container contained within an applicator sleeve with the applicator tip. This Stylus applicator tray is contained in an outer Tyvek pouch. When SURGISEAL is applied to the skin, it polymerizes in minutes.
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    K Number
    K123936
    Device Name
    SURGISEAL TOPICAL SKIN ADHESIVE
    Manufacturer
    Adhezion Biomedical, LLC
    Date Cleared
    2013-04-24

    (125 days)

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

    Adhezion Biomedical, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    SURGISEAL Topical Skin Adhesive is intended for topical applications only to hold closed easily approximated skin edges of wounds from surgical incisions, including punctures from minimally invasive surgery, simple, thoroughly cleansed, trauma induced lacerations. SURGISEAL may be used in conjunction with, but not in place of, deep dermal sutures.
    Device Description
    SURGISEAL® Topical Skin Adhesive is a sterile, professional liquid skin adhesive containing a monomeric (2-ocylt cyanoacrylate) formulation and the colorant D&C Violet #2. Each applicator consists of a thermoformed blister tray with a heat sealed lid with an attached applicator sponge tip. This applicator tray with sponge tip is contained in an outer Tyvek pouch.
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