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

    BENDABLE TISSUE COAGULATING ELECTRODE WITH BENDING TOOL

    K Number: K970809 · Decision Jun 18, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    823
    Registration Numbers
    823
    Same Product Code
    2306
    Applicant Total
    16
    Review Days
    105

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    Basic Information

    Device Name
    BENDABLE TISSUE COAGULATING ELECTRODE WITH BENDING TOOL
    K Number
    K970809
    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
    Somnus Medical Technologies, Inc.
    Date Received
    March 5, 1997
    Decision Date
    June 18, 1997
    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 Somnus Medical Technologies, Inc.

    K Number Device Name
    K000720 SOMNUS DISPOSABLE TISSUE COAGULATING ELECTRODE AND SOMNUS REUSABLE CONNECTOR CABLE
    K001438 SOMNUS MODEL S2 ELECTROSURGICAL GENERATOR
    K000501 ELECTROSURGICAL GENERATOR, MODEL S1
    K982717 SOMNOPLASTY SYSTEM, MODELS S2, 1010/2010,2000/1000,1100,3000/30XX/6000, 1200
    K973701 SOMNUS TISSUE COAGULATING ELECTRODE
    K970837 SOMNUS MODEL 6000 DISPOSABLE TISSUE COAGULATING ELECTRODE
    K970838 SOMNUS MODEL 30XX DISPOSABLE TRI-NEEDLE COAGULATING ELECTRODE
    K973618 SOMNOPLASTY SYSTEM
    K971450 SOMNOPLASTY SYSTEM
    K971711 SOMNUS MODEL 215 ELECTROSURGICAL GENERATOR
    Search all 16 clearances from Somnus Medical Technologies, Inc. →