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Comment: The applicant commented that FDA first issued the VersaVue TM Single-Use Flexible Cystoscope 510(k) clearance in 2023, that the VersaVue TM Single-Use Flexible Cystoscope was not receiving payment as an outpatient service as of December 31, 1996, and that it is not described by any current or previous device categories

This disruption in vascular regulation could lead to inadequate perfusion of neural tissues, exacerbating neuronal vulnerability to ischemic insults and oxidative stress (Lambrechts et al