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

    SINGLE USE & MULTI USE BIPOLAR FORCEPS / SINGLE USE & MULTI USE MONOPOLAR FORCEPS

    K Number: K130669 · Decision Dec 6, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    823
    Registration Numbers
    823
    Same Product Code
    2306
    Applicant Total
    5
    Review Days
    269

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    Basic Information

    Device Name
    SINGLE USE & MULTI USE BIPOLAR FORCEPS / SINGLE USE & MULTI USE MONOPOLAR FORCEPS
    K Number
    K130669
    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
    Olsen Medical
    Date Received
    March 12, 2013
    Decision Date
    December 6, 2013
    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 Olsen Medical

    K Number Device Name
    K111262 ELECTROSURGICAL MONOPOLAR CABLE/ADAPTERS, ELECTROSURGICAL BIPOLAR CABLE/ ADAPTERS, BIPOLAR ELECTROSURGICAL CABLES, MONOP
    K080187 OLSEN MEDICAL SINGLE USE BAYONET BIPOLAR IRRIGATING FORCEPS
    K072937 OLSEN MEDICAL INTEGRATED IRRIGATION TUBING AND BIPOLAR CORD SET
    K042073 OLSEN MEDICAL ANTERIOR CERVICAL VERTEBRAE PLATE SYSTEM