LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K981310
    Device Name
    MAGNATEK C-300
    Manufacturer
    MAGNA ADVANCED TECHNOLOGIES, INC.
    Date Cleared
    1998-07-09

    (90 days)

    Product Code
    GEI
    Regulation Number
    878.4400
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    MAGNATEK C-300

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

    C-300 Coagulator is used in small surgical procedures in The dermatology, plastic surgery and general surgery in order to only coagulate (burn) an open wound or skin lesions. This device does not cut the skin, it only closes open wounds or lesions by coagulating (burning) the skin in any of the small surgical procedures mentioned above.

    Device Description

    Coagulator Device Name: C-300

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for a device called "MagnaTek C-300 Coagulator". It does not contain information about acceptance criteria or a study proving the device meets them. This type of information is typically found in the 510(k) submission itself, not in the clearance letter.

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

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1