BEUDAMED
    Product Code: PQM FDA class 2 21 CFR 878.5050

    Surgical Smoke Precipitator

    General, Plastic Surgery

    The Surgical Smoke Precipitator is a device intended to precipitate surgical smoke generated during laparoscopic surgeries using smoke-producing surgical tools, enabling surgeons to adequately visualize the operative field. It is classified as FDA Class 2 under 21 CFR 878.5050 in the General and Plastic Surgery specialty, requiring 510(k) premarket notification. The device addresses a patient and staff safety concern by clearing smoke during minimally invasive procedures. Product code PQM; not an implant and not life-sustaining.

    View on FDA
    510(k)s
    7
    FEI Numbers
    5
    Registration Numbers
    5
    Unique Applicants
    2
    Years Active
    8

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    Basic Information

    Product Code
    PQM
    Device Class
    FDA class 2
    Regulation Number
    878.5050
    Medical Specialty
    General, Plastic Surgery
    Review Panel
    HO
    Submission Type
    1

    Device Characteristics

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

    Definition

    The device is intended to precipitate surgical smoke to allow surgeons adequately visualize laparoscopic surgeries in the using surgical smoke/aerosolized particulate surgical tools.

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 7 510(k) clearances via K numbers.

    K Number Device Name
    K240868 Ultravision2™ IonPencil
    K231298 Ultravision2™ System Integrated Monopolar L-Hook (H/S)™
    K231238 Ultravision2™ System
    K200035 Ultravision Visual Field Clearing System
    K182053 Ultravision™ Visual Field Clearing System
    K170178 Ultravision Visual Field Clearing System
    DEN150022 Ultravision Visual Clearing System

    FEI Numbers

    This FDA classification entry is associated with 5 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 5 registration numbers. Click on an entry to view related FDA registrations.