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However, we maintain our concern regarding the lack of data comparing the VersaVue TM Single-Use Flexible Cystoscope to other single-use, disposable and reusable, reprocessed cystoscopes

We disagree with the applicant's assertions that the IRP monitoring capabilities that make the LithoVue TM Elite Ureteroscope unique merit a new pass-through device category because the LithoVue TM Elite Ureteroscope is consistent with C1747, regardless of the presence of the additional pressure sensing feature, as a few commenters noted