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510(k) Data Aggregation

    K Number
    K211173
    Device Name
    maxmorespine Bipolar Electrodes
    Date Cleared
    2022-06-23

    (429 days)

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

    Hoogland Spine Products, GmbH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The maxmorespine Bipolar Electrodes are indicated for the coagulation of soft tissue during open or minimally invasive surgical procedures when used in conjunctible radio frequency generator. The maxmorespine Bipolar Electrodes have not been shown to be effective for tubal coagulation for sterilization for sterilization procedures and should not be used for these procedures.
    Device Description
    maxmorespine Bipolar Electrodes are designed with a rounded distal end, an ergonomic handle in various designs and a flat plug connection. The electrodes are sold as one-piece electrodes (1001-BE 003) or consist of a three-piece construction (shaft, electrode and handle). The one-piece electrode and electrodes (1001-BE 002 and 1001-BE 004) are sold as sterile, single-use devices. The handles and shafts (1001-BE 001/H, 1001-BE 001/s and 1001-BE 004/S) are intended for reuse. The maxmorespine Bipolar Electrodes can be connected to HF electrosurgical generators that have the permissible Vp voltage via a flat plug using the standard bipolar connection cables.
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