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510(k) Data Aggregation

    K Number
    K984177
    Device Name
    MODIFICATION TO SKVEKPATCH
    Manufacturer
    MARINE POLYMER TECHNOLOGIES, INC.
    Date Cleared
    1998-12-18

    (28 days)

    Product Code
    KMF
    Regulation Number
    880.5090
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    N/A
    Predicate For
    K012293,K021062,K030334,K030946,K032986,K040208,K053300,K070557,K143466
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    ProDein™Patch is indicated for use in the local management of bleeding wounds such as lacerations, abrasions and nose bleeds.

    SyvekPatch™ is intended for use under the direction of a healthcare professional for the following indications: SyvekPatch™ is indicated for the promotion of rapid control of bleeding in patients following hemodialysis and in patients on anticoagulation therapy. SyvekPatch™ is indicated for use in the local management of bleeding wounds such as vascular access site, percutaneous catheters or tubes and surgical debridement.

    Device Description

    Not Found

    AI/ML Overview

    The provided document is an FDA 510(k) clearance letter for two devices: Syvekpatch (prescription) and Prodein (over-the-counter). It does not contain any information about acceptance criteria, device performance, or any studies conducted to prove the device meets acceptance criteria.

    The document primarily focuses on:

    • Substantial Equivalence Determination: The FDA determined that the devices are substantially equivalent to devices marketed prior to May 28, 1976.
    • Limitations on Labeling: Specific claims the device cannot make (e.g., accelerating wound healing, long-term dressing, treatment/cure).
    • Indications for Use:
      • ProDein™ Patch: Local management of bleeding wounds such as lacerations, abrasions, and nosebleeds.
      • SyvekPatch™: Under the direction of a healthcare professional for rapid control of bleeding following hemodialysis, in patients on anticoagulation therapy, and local management of bleeding wounds such as vascular access sites, percutaneous catheters/tubes, and surgical debridement.
    • Regulatory Information: General controls provisions, annual registration, GMP compliance, and other federal laws.

    Therefore, I cannot provide the requested information regarding acceptance criteria and studies from this document.

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