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

    MODEL 20-C, RL-20A/U, OB-10A/U

    K Number: K872709 · Decision Feb 2, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4
    Same Product Code
    47
    Applicant Total
    39
    Review Days
    210

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    Basic Information

    Device Name
    MODEL 20-C, RL-20A/U, OB-10A/U
    K Number
    K872709
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.4550
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Applicant
    Directed Energy, Inc.
    Date Received
    July 7, 1987
    Decision Date
    February 2, 1988
    Product Code
    HHR
    Advisory Committee
    Obstetrics/Gynecology
    Review Advisory Committee
    OB
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    HHR Laser, Surgical, Gynecologic

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    Other Clearances by Directed Energy, Inc.

    K Number Device Name
    K904930 SURGICAL CARBON DIOXIDE LASER SYST MODEL 20-CH
    K894241 MODEL 20-CH W/ AR-10A/U OPTICAL ATTACHMENT
    K883738 CARBON DIOXIDE LASER SYSTEM MODEL 20-CX W/ATTACH.
    K882926 MODEL AU-1 ACCESSORY UNIT
    K880216 MODEL 20C W/AN AR-10A/U & RL-20A/U FOR ARTHROSCOP.
    K873331 ORTHO. GAS INSUFFLATOR MODEL IN-2 FOR ARTHRO. SURG
    K870841 MODEL 20-C W/BR-20A/U ATTACH/MODEL HL-3.0 OB/GYN
    K872711 MODEL 20-C W/AR-10A/U ATTACH. FOR ARTHRO. SURGERY
    K872710 MODEL 20-B W/OB-10A/U ATTACH. FOR EAR, NOSE/THROAT
    K870840 MODEL 20-C W/BR-20A/U ATTACH/MODEL HL-3.O ATTACH
    Search all 39 clearances from Directed Energy, Inc. →