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510(k) Data Aggregation

    K Number
    K993527
    Device Name
    LOOP ELECTRODE, BALL ELECTRODE
    Manufacturer
    PALM MEDICAL USA, INC.
    Date Cleared
    2000-07-06

    (262 days)

    Product Code
    HGI
    Regulation Number
    884.4120
    Why did this record match?
    Applicant Name (Manufacturer) :

    PALM MEDICAL USA, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Indication for the LLETZ procedure include: A cytological and coposcopic suspicion of CIN; A transformation zone which is fully visible and fully confined to the cervix; LLETZ in indicated for those patients who have had abnormal pap smear report with cytologic evidence of CIN, colposcopic examination of the cervix unsatisfactory finding and who, in the physician's opinion are suitable candidates for the procedure.
    Device Description
    Not Found
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