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510(k) Data Aggregation

    K Number
    K020921
    Device Name
    NO-POKES NEEDLE SAFETY DEVICE
    Manufacturer
    BEMIS MFG. CO.
    Date Cleared
    2002-07-11

    (112 days)

    Product Code
    FMI
    Regulation Number
    880.5570
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    NO-POKES NEEDLE SAFETY DEVICE

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    NO-POKES™ is a disposable needle recapping aid that helps prevent recapping injury by providing repository for the needle cap (other than the user's hand) in which to place the cap while using the syringe. This keeps the user's hand away from the needle during uncapping and recapping.

    The cap of the capped needle is placed in the NO-POKES™ . The "wax-like" substance in the NO-POKES™ holds the cap securely while the operator uses the needle. After the procedure, while the cap is secured in the NO-POKES™, the operator inserts the needle back into the cap without exposing his/her hand to the needle. The NO-POKES™ container has an adhesive on the base to hold it to the desired surface while in use.

    Device Description

    NO-POKES™ is a disposable needle recapping aid that helps prevent recapping injury by providing repository for the needle cap (other than the user's hand) in which to place the cap while using the syringe. This keeps the user's hand away from the needle during uncapping and recapping.

    The cap of the capped needle is placed in the NO-POKES™ . The "wax-like" substance in the NO-POKES™ holds the cap securely while the operator uses the needle. After the procedure, while the cap is secured in the NO-POKES™, the operator inserts the needle back into the cap without exposing his/her hand to the needle. The NO-POKES™ container has an adhesive on the base to hold it to the desired surface while in use.

    AI/ML Overview

    The provided document is a 510(k) premarket notification letter from the FDA for a device called "No-Pokes Needle Safety Device (Recapper)". This document does not contain any information regarding acceptance criteria, study details, or performance data for the device.

    Therefore, I cannot provide the requested information. The document focuses on the regulatory clearance of the device based on its substantial equivalence to a predicate device.

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