BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    SecurePortIV Catheter Securement Adhesive

    K Number: K170505 · Decision Sep 29, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    9
    Same Product Code
    3
    Applicant Total
    10
    Review Days
    220

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    Basic Information

    Device Name
    SecurePortIV Catheter Securement Adhesive
    K Number
    K170505
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4370
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Adhezion Biomedical, LLC
    Date Received
    February 21, 2017
    Decision Date
    September 29, 2017
    Product Code
    NZP
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    NZP Sealant, Microbial

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (NZP), ordered by most recent decision date.

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    INTEGUSEAL MICROBIAL SEALANT, MODEL IS 100 AND 1S200

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    Other Clearances by Adhezion Biomedical, LLC

    K Number Device Name
    K223669 SecurePortIV Advanced Catheter Securement Adhesive
    K161011 SURGISEAL Topical Skin Adhesive, SURGISEAL Stylus Topical Skin Adhesive, SURGISEAL Twist Topical Skin Adhesive
    K150866 SURGISEAL Topical Skin Adhesvie
    K133963 SURGISEAL TWIST (TM) TOPICAL SKIN ADHESIVE
    K141215 SURGISEAL TWIST TOPICAL SKIN ADHESIVE
    K140517 SURGISEAL TOPICAL SKIN ADHESIVE/SURGISEAL STYLUS TOPICAL SKIN ADHESIVE
    K130329 SURGISEAL TOPICAL SKIN ADHESIVE
    K130474 SURGISEAL TOPICAL SKIN ADHESIVE
    K123936 SURGISEAL TOPICAL SKIN ADHESIVE