BEUDAMED
    Product Code: FFI FDA class 2 21 CFR 876.4300

    System, Alarm, Electrosurgical

    Gastroenterology, Urology

    The Electrosurgical Alarm System is a safety device used in the gastroenterology and urology operating environment to monitor and alert clinicians to potentially hazardous conditions during electrosurgical procedures. It is classified as FDA Class 2, requiring 510(k) premarket notification, and is eligible for third-party 510(k) review. The product code is FFI, regulated under 21 CFR 876.4300, within the Gastroenterology, Urology specialty.

    View on FDA
    510(k)s
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Unique Applicants
    1
    Years Active
    —

    Basic Information

    Product Code
    FFI
    Device Class
    FDA class 2
    Regulation Number
    876.4300
    Medical Specialty
    Gastroenterology, Urology
    Review Panel
    GU
    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 1 510(k) clearance via K numbers.

    K Number Device Name
    K843214 EPHAR