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510(k) Data Aggregation

    K Number
    K101711
    Device Name
    CERULEAU ELECTROSURGICAL PROBE
    Date Cleared
    2010-07-01

    (13 days)

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

    NUORTHO SURGICAL, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The NuOrtho CERULEAU™ Probes are indicated for resection, coagulation of soft tissue and hemostasis of blood vessels in arthroscopic and orthopedic procedures. These procedures include the following indications: Resection and Excision (Acetabular Labrum, Articular Labrum, Capsule, Capsular Release, Cartilage Flaps, Cysts, Discoid Meniscus, Frozen Shoulder Release, Glenoid Labrum, Labral Tear, Lateral Release, Ligament, Loose Bodies, Meniscal Cystectomy, Meniscectomy, Plica Removal, Scar Tissue, Soft Tissue, Synovial Membrane, Tendon, Triangular Fibrocartilage (TFCC), Villusectomy), Debridement (ACL/PCL, Acromioplasty, Articular Cartilage, Bursectomy, Chondroplasty, Fascia, Ligament, Notchplasty, Scar Tissue, Soft Tissue, Subacromial Decompression, Synovectomy, Tendon), Coagulation (ACL/PCL, Articular Cartilage, Carpal Ligaments, Glenohumeral Capsule, Ligament, Medial Retinaculum, Rotator Cuff, Tendon, Wrist Tendons).
    Device Description
    The CERULEAU™ Electrosurgical Probe is a bipolar device designed to direct radiofrequency energy from an electrosurgical generator into target tissue during arthroscopic and orthopedic surgical procedures. Ceruleau delivers non-ablation, low-level amounts of radiofrequency energy to the treatment site. The radiofrequency energy is delivered via a protected electrode geometry which inhibits direct electrode-to-tissue contact. Design of the electrode's protective housing can function as a mechanical implement for use adjunct to energy delivery.
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