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

    DISPOSABLE ELECTROSURGERY BALL ELECTRODE

    K Number: K925708 · Decision Apr 20, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    7
    Registration Numbers
    7
    Same Product Code
    3
    Applicant Total
    18
    Review Days
    159

    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
    DISPOSABLE ELECTROSURGERY BALL ELECTRODE
    K Number
    K925708
    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
    Beacon Laboratories, Inc.
    Date Received
    November 12, 1992
    Decision Date
    April 20, 1993
    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

    TECH-SWITCH ELECTROSURGICAL PENCIL, SINGLE USE

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

    HAND-TROL S

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

    Other Clearances by Beacon Laboratories, Inc.

    K Number Device Name
    K930243 FLEXIBLE EXTENDER
    K930497 ARGON HANDPIECES
    K922289 SESQUIPOLAR(TM) MIS ELECTRODE
    K925619 DISPOSABLE HAND-SWITCHING ESU PENCIL
    K915788 MIS ELECTROSURGICAL ELECTRODES
    K920100 GSU HANDPIECE ADAPTER
    K913772 PRESSURE GUARD
    K905752 ARGON BEAM COMBO LAPAROSCOPIC ELECTRODE
    K904506 ACTIVE ADAPTER
    K902996 ARGON BEAM LAPAROSCOPIC ELECTRODE
    Search all 18 clearances from Beacon Laboratories, Inc. →