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We note that we expressed similar concerns relating to the lack of comparative studies between the single-use Uretero1 TM device and other disposable devices and indicated that, while we ultimately agreed that the totality of evidence demonstrated improved patient outcomes and reduced patient risk associated with the disposable device in comparison with reusable devices represents substantial clinical improvement, we stated it would have been helpful to see comparative studies (87 FR 71932)

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LB, RS, MDS, VH, AF, and RM added important intellectual content writing, criticizing, and correcting previous versions of the manuscript