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510(k) Data Aggregation

    K Number
    K253024
    Device Name
    ProZip Knotless Implant
    Manufacturer
    Riverpoint Medical
    Date Cleared
    2025-10-16

    (27 days)

    Product Code
    GAT
    Regulation Number
    878.5000
    Type
    Special
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    K190817
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The ProZip Knotless Implant is intended for use in soft-tissue approximation.

    Device Description

    The ProZip Knotless Implant is comprised of braided ultra-high molecular weight polyethylene (UHMWPE) and Polyester sutures. It contains one working suture, also referred to as the repair strand, and shuttle strand that is used to shuttle the repair strand around the tissue. Additionally, the repair strand has a suture attached at either end to aid in passing through tissue, known as adaptor tail.

    Sutures supplied meet United States Pharmacopeia (USP) requirements for non-absorbable suture except for diameter. Suture dyes are FDA approved. The device is sterilized by ethylene oxide gas and is provided sterile for single use. The device is intended for use in a hospital/clinic/surgical setting.

    AI/ML Overview

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