BEUDAMED
    Product Code: NZP FDA class 2 21 CFR 878.4370

    Sealant, Microbial

    General, Plastic Surgery

    The Sealant, Microbial (product code NZP) is a surgical sealant intended to isolate the site of a surgical incision from microbial contamination, indicated to reduce the risk of skin flora contamination of the surgical incision throughout a surgical procedure. It is classified as FDA Class 2, requiring 510(k) clearance, and is regulated under 21 CFR 878.4370 within the General and Plastic Surgery specialty. The device carries no implant or life-sustaining flags.

    View on FDA
    510(k)s
    4
    FEI Numbers
    9
    Registration Numbers
    9
    Unique Applicants
    3
    Years Active
    17

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    Basic Information

    Product Code
    NZP
    Device Class
    FDA class 2
    Regulation Number
    878.4370
    Medical Specialty
    General, Plastic Surgery
    Review Panel
    HO
    Submission Type
    1

    Device Characteristics

    ✗
    GMP Exempt
    ✗
    Implant
    ✗
    Life Sustain/Support
    ✗
    Third Party
    —
    Summary Malfunction Reporting

    Definition

    Intended to isolate the site of a surgical incision from microbial contamination and indicated to reduce the risk of skin flora contamination of the surgical incision throughout a surgical procedure.

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 4 510(k) clearances via K numbers.

    K Number Device Name
    K223669 SecurePortIV Advanced Catheter Securement Adhesive
    K170505 SecurePortIV Catheter Securement Adhesive
    K083354 FLORASEAL, MODEL FS350D
    K052870 INTEGUSEAL MICROBIAL SEALANT, MODEL IS 100 AND 1S200

    FEI Numbers

    This FDA classification entry is associated with 9 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 9 registration numbers. Click on an entry to view related FDA registrations.