LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K971408
    Device Name
    SEVRAIN CRANIAL CLAMP (SCC-200 SERIES)
    Manufacturer
    IKONOS CORP.
    Date Cleared
    1998-05-12

    (391 days)

    Product Code
    GXN
    Regulation Number
    882.5330
    Type
    Traditional
    Panel
    Neurology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    SEVRAIN CRANIAL CLAMP (SCC-200 SERIES)

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

    The SCC 200 is indicated for use as a means to cover the burr hole and reattach the bone flap after a craniotomy procedure. The SCC 200 is not intended for use where only a single burr hole is made.

    Device Description

    Sevrain Cranial Clamp 200 Series (Polyethylene)

    AI/ML Overview

    I am sorry, but this document is an FDA 510(k) clearance letter for a medical device called the "Sevrain Cranial Clamp 200 Series." This type of document does not contain the information requested in your prompt regarding acceptance criteria, study details, sample sizes, expert qualifications, or ground truth establishment.

    The letter simply states that the FDA has reviewed the manufacturer's notification and determined that the device is substantially equivalent to legally marketed predicate devices, allowing it to proceed to market. It does not elaborate on the specific performance studies or data used to reach this determination.

    Therefore, I cannot provide the requested information from this document.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1