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

    OPTHERM EXTRA FINE TIP

    K Number: K840426 · Decision May 9, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    20
    Registration Numbers
    20
    Same Product Code
    23
    Applicant Total
    31
    Review Days
    99

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    Basic Information

    Device Name
    OPTHERM EXTRA FINE TIP
    K Number
    K840426
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    886.4115
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Applicant
    Suncoast Medical Manufacturers, Inc.
    Date Received
    January 31, 1984
    Decision Date
    May 9, 1984
    Product Code
    HQP
    Advisory Committee
    Ophthalmic
    Review Advisory Committee
    OP
    Third Party
    N

    Classifications

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

    Product Code Device Name
    HQP Unit, Cautery, Thermal, Battery-Powered

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    Other Clearances by Suncoast Medical Manufacturers, Inc.

    K Number Device Name
    K841604 ADJUST-A-TEMP HIGH TEMPERATURE
    K841459 REPLACE-A-TIP ADJUST. LOW TEMP.-
    K841509 REPLACE-A-TIP ADJUSTABLE HIGH TEMP.
    K841603 ADJUST-A-TEMP MICRO
    K841591 PYRO-TIP
    K840376 SURG-A STAT LOOP TIP
    K840375 SURG-A-STAT LOOP TIP 15
    K840387 SURG-A-STAT LOOP TIP 2
    K840370 SURG-A-STAT VASECTOMY TIP
    K840377 SURG-A-STAT CARDIOVASCULAR TIP
    Search all 31 clearances from Suncoast Medical Manufacturers, Inc. →