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Third, in the second, third, fourth and fifth claims, the applicant asserted that the use of single-use, disposable cystoscopes avoids post-cystoscopy infections, device malfunctions, and contamination problems associated with reusable devices, and eliminates the need for reprocessing and avoids the risk of infection associated with improper reprocessing

however, this is FDA staff's proposed position going into the meeting, not a final action, and the committee's discussion, any vote, and FDA's ultimate decision are still pending, so the outcome of the review is not yet known

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