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

    WALLACH QUANTUM 500 ELECTROSURGICAL GENERATOR

    K Number: K983208 · Decision Feb 22, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    823
    Registration Numbers
    823
    Same Product Code
    2306
    Applicant Total
    27
    Review Days
    161

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    Basic Information

    Device Name
    WALLACH QUANTUM 500 ELECTROSURGICAL GENERATOR
    K Number
    K983208
    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
    Wallach Surgical Devices, Inc.
    Date Received
    September 14, 1998
    Decision Date
    February 22, 1999
    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 Wallach Surgical Devices, Inc.

    K Number Device Name
    K021224 ENDOCERVICAL BLOCK NEEDLE
    K020711 WALLACH LOOP ELECTRODE
    K000768 WALLACH QUANTUM 500 ELECTROSURGICAL GENERATOR
    K992736 WALLACH'S ULTIMATE REUSABLE, PLASTIC VAGINAL SPECULUM
    K991669 PMS 750 FINGERSWITCH
    K983840 WALLACH QUANTUM 500 ELECTROSURGICAL GENERATOR (PROPOSED)
    K984306 `THE INSEMINATOR' (PROPOSED)
    K963653 WALLACH QUANTUM 2000 ELECTROSURGICAL SYSTEM
    K963348 WALLACH INTEGRATION UNIT
    K950630 WALLACH DIGITAL IMAGING SYSTEM
    Search all 27 clearances from Wallach Surgical Devices, Inc. →