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510(k) Data Aggregation

    K Number
    K252043
    Device Name
    Bipolar applicator CelonProBreath (WB990310); Bipolar applicator CelonProSleep plus (WB990311); Bipolar applicator CelonProBreath (WB990210); Bipolar applicator CelonProSleep plus (WB990211)
    Manufacturer
    Olympus Winter & Ibe GmbH
    Date Cleared
    2025-09-23

    (85 days)

    Product Code
    GEI
    Regulation Number
    878.4400
    Type
    Traditional
    Panel
    Ear Nose & Throat
    Reference & Predicate Devices
    K032838
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Bipolar applicator CelonProBreath is intended for use with a compatible electrosurgical generator. This method of treatment is also called bipolar Radiofrequency Induced Thermotherapy (RFITT).

    Bipolar applicator CelonProBreath is indicated for ablation and coagulation of soft tissue in otorhinolaryngeal surgery, specifically:

    • Shrinkage of submucosal tissue in nasal airway obstruction by reduction of hypertrophic nasal turbinates.

    The product is intended to be used for patients from 2 years and up.

    Bipolar applicator CelonProSleep plus is intended for use with a compatible electrosurgical generator. This method of treatment is also called bipolar radiofrequency induced thermotherapy (RFITT).

    Bipolar applicator CelonProSleep plus is indicated for ablation and coagulation of soft tissue in otorhinolaryngeal surgery, specifically:

    • Shrinkage of submucosal tissue and tissue coagulation in the soft palate for the treatment of snoring.

    The product is intended to be used for patients from 18 years up.

    Device Description

    The devices subject to this submission are sterile, single-use devices: the bipolar applicator CelonProBreath (WB990210 and WB990310) and the bipolar applicator CelonProSleep plus (WB990211 and WB990311). The devices are for use with a compatible electrosurgical generator. This method of treatment is also called bipolar radiofrequency induced thermotherapy (RFITT). The devices are intended for the ablation and coagulation of soft tissue in otorhinolaryngeal surgery.

    Bipolar applicator CelonProBreath (WB990210 and WB990310) is specifically used for shrinkage of submucosal tissue in nasal airway obstruction by reduction of hypertrophic nasal turbinates.

    Bipolar applicator CelonProSleep plus (WB990211 and WB990311) is specifically used for shrinkage of submucosal tissue and tissue coagulation in the soft palate for the treatment of snoring.

    AI/ML Overview

    N/A

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