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510(k) Data Aggregation

    K Number
    K984106
    Device Name
    MAMMARY SIZER, MAMMARY PROTHESIS SIZER
    Manufacturer
    SPECIALTY SURGICAL PRODUCTS, INC.
    Date Cleared
    1999-02-12

    (87 days)

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

    MAMMARY SIZER, MAMMARY PROTHESIS SIZER

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

    The mammary sizer is designed for single use, temporary intraoperative placement in a surgically created pocket. The sizer is used to evaluate the appropriate mammary prosthesis volume for each patient prior to implantation of a mammary prosthesis.

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) clearance letter for a device called "Mammary Sizer." It does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth details. The letter confirms that the device is substantially equivalent to legally marketed predicate devices, allowing it to be marketed.

    Therefore, I cannot provide the requested information based on the provided text.

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