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510(k) Data Aggregation

    K Number
    K982991
    Device Name
    ANSPACH ACCESS CRANIAL PERFORATOR
    Manufacturer
    THE ANSPACH EFFORT, INC.
    Date Cleared
    1998-10-21

    (55 days)

    Product Code
    HBF
    Regulation Number
    882.4305
    Type
    Traditional
    Panel
    Neurology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    ANSPACH ACCESS CRANIAL PERFORATOR

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

    For performing cranial trephination.

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for a medical device called the "Anspach Access Cranial Perforator". It confirms that the device is substantially equivalent to legally marketed predicate devices.

    The information provided in this clearance letter does not contain any details about acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, or ground truth establishment.

    Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets those criteria using only the provided text. The document is a regulatory approval notice, not a technical report detailing the device's validation.

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