BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    TECH-SWITCH ELECTROSURGICAL PENCIL, SINGLE USE

    K Number: K932345 · Decision Apr 12, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    7
    Registration Numbers
    7
    Same Product Code
    3
    Applicant Total
    92
    Review Days
    333

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    TECH-SWITCH ELECTROSURGICAL PENCIL, SINGLE USE
    K Number
    K932345
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4400
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Conmedcorp
    Date Received
    May 14, 1993
    Decision Date
    April 12, 1994
    Product Code
    DWG
    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
    DWG Electrosurgical Device

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (DWG), ordered by most recent decision date.

    MAHE INSTRUMENTS

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    HAND-TROL S

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    DISPOSABLE ELECTROSURGERY BALL ELECTRODE

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery
    View all

    Other Clearances by Conmedcorp

    K Number Device Name
    K101534 CONMED ALTRUS THERMAL TISSUE FUSION SYSTEM
    K061021 ENTAKE STANDARD AND SAFETY PEG SYSTEM
    K050992 CONMED IRRIGATION NOZZLE
    K050777 PROFORMA HF 4.5 CANNULA, MODEL 050906, 050907
    K050304 FX WIRE ADVANCED MEASUREMENT GUIDEWIRE
    K041953 VERSASTIM, PERFOAMAX, SURGI-STIM, FASTSTART
    K021079 ABCSNARE ELECTROSURGICAL PROBE FOR FLEXIBLE ENDOSCOPES, MODEL 1336XX
    K021299 CONMED HEATWAVE HAND-CONTROLLED ELETRODE
    K020135 CONMED SYSTEM 2000 ELECTROSURGICAL GENERATOR, REF: 60-8002; CONMED ESU CART, REF: 60-6120
    K020186 CONMED SYSTEM 5000 ESU
    Search all 92 clearances from Conmedcorp →