BEUDAMED
    Product Code: JOT FDA class 2 21 CFR 878.4400

    Electrode, Gel, Electrosurgical

    General, Plastic Surgery

    The Electrode, Gel, Electrosurgical is a surgical device consisting of an electrosurgical electrode incorporating a conductive gel medium, used to deliver controlled radiofrequency electrical current to tissue for surgical cutting or coagulation in general and plastic surgery applications. This device is FDA Class 2, indicating moderate risk and requiring 510(k) premarket notification before marketing. It carries product code JOT and is regulated under 21 CFR 878.4400, within the General, Plastic Surgery medical specialty. This device is eligible for third-party 510(k) review.

    View on FDA
    510(k)s
    9
    FEI Numbers
    0
    Registration Numbers
    0
    Unique Applicants
    9
    Years Active
    12

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    Basic Information

    Product Code
    JOT
    Device Class
    FDA class 2
    Regulation Number
    878.4400
    Medical Specialty
    General, Plastic Surgery
    Review Panel
    SU
    Submission Type
    1

    Device Characteristics

    ✗
    GMP Exempt
    ✗
    Implant
    ✗
    Life Sustain/Support
    ✓
    Third Party
    —
    Summary Malfunction Reporting

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 9 510(k) clearances via K numbers.

    K Number Device Name
    K923647 RFG-DGP DISPOSABLE GROUNDING PADS
    K905545 ULTRASOUND TRANSMISSION GEL
    K904418 ULTRASOUND COUPLING GEL
    K901217 TRIA-SONIC ULTRA SOUND TRANSMISSION GEL
    K894490 STERILE ULTRASOUND TRANSMISSION GEL
    K884503 ULTRASONIC TRANSMISSION GEL
    K872519 STERILIZED OMNI GEL
    K871565 ULTRASOUND TRANSDUCER GEL, STERILE
    K800933 R2 ELECTROSURG. RETURN ELECT. #225ETC.