BEUDAMED
    Product Code: PYO FDA class 1 21 CFR 880.5240

    Tape And Bandage, Adhesive, Adjustable Closing Mechanism, Otc Use

    General Hospital

    The Tape and Bandage, Adhesive, Adjustable Closing Mechanism, OTC Use is a medical device consisting of a strip of fabric or plastic material coated on one side with an adhesive, used over-the-counter to cover and protect wounds, hold together skin edges of a wound, support an injured body part, or secure objects to the skin. It is classified as a Class 1 device under regulation 880.5240, subject to general controls only and exempt from 510(k) premarket notification. The product code is PYO, and it falls within the General Hospital (HO) medical specialty, reviewed by the Surgery panel. It is not an implant and is not life-sustaining.

    View on FDA
    510(k)s
    1
    FEI Numbers
    50
    Registration Numbers
    50
    Unique Applicants
    1
    Years Active
    —

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    Basic Information

    Product Code
    PYO
    Device Class
    FDA class 1
    Regulation Number
    880.5240
    Medical Specialty
    General Hospital
    Review Panel
    SU
    Submission Type
    4

    Device Characteristics

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

    Definition

    A device intended for medical purposes that consists of a strip of fabric material or plastic, coated on one side with an adhesive, and may include a pad of surgical dressing without a disinfectant. The device is used to cover and protect wounds, to hold together the skin edges of a wound, to support an injured part of the body, or to secure objects to the skin

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 1 510(k) clearance via K numbers.

    K Number Device Name
    K170003 Zip 4 Skin Closure Device

    FEI Numbers

    This FDA classification entry is associated with 50 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 50 registration numbers. Click on an entry to view related FDA registrations.