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510(k) Data Aggregation

    K Number
    K170726
    Device Name
    Biopsy Forceps
    Manufacturer
    Fehling Instruments GmbH & Co. KG
    Date Cleared
    2017-06-02

    (85 days)

    Product Code
    DWZ
    Regulation Number
    870.4075
    Why did this record match?
    Applicant Name (Manufacturer) :

    **Fehling Instruments GmbH **& Co

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    FEHLING biopsy forceps are used to obtain endomyocardial biopsy specimens from the right and left ventricle via percutaneous arterial or venous approach.
    Device Description
    The Biopsy Forceps are designed to allow percutaneous access to the right or left ventricles of the heart to obtain diagnostic tissue samples. The forceps consist of three main components: - an actuating handle ergonomically designed for comfortable use, 1. - 2. a flexible shaft, - and surgical stainless steel cutting jaws. 3. At the distal end of the forceps is a pair of stainless steel jaws used to obtain the tissue samples. At the proximately end of the forceps is the actuation handle used to activate the jaws and steer the device. The product is provided single for use and sterile.
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    K Number
    K153243
    Device Name
    Fehling-Punches
    Manufacturer
    Fehling Instruments GmbH & Co. KG
    Date Cleared
    2016-08-04

    (269 days)

    Product Code
    HAE, DEV
    Regulation Number
    882.4840
    Why did this record match?
    Applicant Name (Manufacturer) :

    **Fehling Instruments GmbH **& Co

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Fehling rongeurs (bone punches) are manually operated instruments indicated for cutting or biting bone during surgery involving the skull or spinal column.
    Device Description
    Fehling-Punches are reusable stainless steel instruments that are coated with CERAMO® that are sterilizable and packaged non-sterile. The instruments are offered in various sizes and with different features to accommodate the variations of patient anatomy and access. Instruments are available with the following features: 0.8-8 mm bite sizes; 9 – 19 mm jaw openings; 40° and 90° up/down cutting angles; up/down curved; reqular and thin profile footplates; standard and ejector tips; 110 - 400 mm shaft lengths; and various handle and shaft styles, detachable and non-detachable. Fehling-Punches are distributed under the following brand names: CERAMO® CONCEPT X, CERAMO® CONCEPT CLASSIC, CERAMO® CONCEPT APART, CERAMO® GENTLE, CERAMO® GENTLE "SINGER", CERAMO® TRADITION X, CERAMO® FIST. CERAMO® EJECTOR, CERAMO® SUBLAMINAR, CERAMO® APART, CERAMO® KERRISION. The instruments are made of stainless steel according to ASTM F899 and are coated with CERAMO®. CERAMO®is an AlTiN coating. A reusable screwdriver (item code TXW-9X) is offered with the Fehling Punches for the assembly and disassembly.
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