BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇰🇷 South Korea

    PROPENCIL Smoke Pencil

    K Number: K143103 · Decision Jul 16, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    823
    Registration Numbers
    823
    Same Product Code
    2306
    Applicant Total
    17
    Review Days
    260

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    Basic Information

    Device Name
    PROPENCIL Smoke Pencil
    K Number
    K143103
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4400
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Bio Protech, Inc.
    Date Received
    October 29, 2014
    Decision Date
    July 16, 2015
    Product Code
    GEI
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    GEI Electrosurgical, Cutting & Coagulation & Accessories

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    Other Clearances by Bio Protech, Inc.

    K Number Device Name
    K192035 EvaQMax Smoke Evacuation System
    K152984 Disposable Concentric Needle electrodes, Disposable Monopolar Needle electrodes, Disposable EP Needle electrodes, Disposable Hypodermic Needle electrodes
    K153019 Disposable Adhesive Surface Electrodes, Disposable/Reusable Cup Electrodes
    K142099 CUTANEOUS ELECTRODES
    K111270 REUSABLE STIMULATING ELECTRODES
    K100246 MAX-IF1000
    K091248 MAXEMS, MODELS 1000 AND 2000
    K092732 PROPENCIL ESU PENCIL
    K092761 PROPLATE, MODELS 9641C, 9641F, P9641C, P9641F, 9642C, 9642F AND P9642C
    K083148 TELECTRODE WET GEL ECG ELECTRODE
    Search all 17 clearances from Bio Protech, Inc. →