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510(k) Data Aggregation

    K Number
    K193591
    Device Name
    ARC 400
    Manufacturer
    BOWA-electronics GmbH & Co. KG
    Date Cleared
    2020-04-02

    (101 days)

    Product Code
    GEI
    Regulation Number
    878.4400
    Why did this record match?
    Applicant Name (Manufacturer) :

    **BOWA-electronics GmbH **& Co

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The High Frequency (HF) device is intended exclusively for the generation of electrical power for monopolar and bipolar cutting and coagulation of tissue structures in surgical operations.
    Device Description
    The ARC 400 (REF: 900-400) is an electrosurgical device. It generates high frequency (HF) electrical current for the purpose of cutting (e.g. removing tissue) or coagulating (e.g. control bleeding) human tissue. It is used with compatible bipolar instruments (e.g. K953509) or with monopolar instruments (e.g. K982743) in combination with a neutral electrode (e.g. K173877). The ARC 400 offers 34 modes that represent four main categories: monopolar cutting (12 modes), monopolar coagulation (9 modes), bipolar cutting (4 modes) and bipolar coagulation (9 modes).
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    K Number
    K173877
    Device Name
    BOWA Neutral Electrodes
    Manufacturer
    BOWA-electronics GmbH & Co. KG
    Date Cleared
    2018-02-15

    (56 days)

    Product Code
    GEI
    Regulation Number
    878.4400
    Why did this record match?
    Applicant Name (Manufacturer) :

    **BOWA-electronics GmbH **& Co

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Disposable neutral electrodes are self-adhesive, ready-to-use and single-use products and are an accessory for HF surgery in monopolar applications. The electrical circuit between the patient and the HF generator on the passive side.
    Device Description
    BOWA Neutral Electrodes for adults, children and neonates provide a safe return path for electrosurgical current. The electrode consists of a conductive adhesive area surrounded by a non-conductive border adhesive. The conductive area is split in longitudinal or circumferential direction which enables a quicker detection of disconnection. The electrode backing is fluid resistant. The neutral electrode is single-use only, disposable, and non-sterile. The electrodes are supplied with or without a pre-attached cable. For the non-pre-corded electrodes, a reusable cable is available as accessory.
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