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Early histological studies examining skin wounds, colon anastomoses, and sponge implantation models evaluated tissue organization parameters such as reticulin fibers, collagen architecture, and blood vessel formation in healing tissue environments [8]

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Second, while we concurred that avoiding post-cystoscopy infections is important, we noted that none of the studies the applicant submitted as evidence evaluated or assessed the VersaVue [TM] Single-Use Flexible Cystoscope and that none of the studies compared clinical outcomes, such as adverse events (including post-cystoscopy infection) associated with the use of the VersaVue [TM] Single-Use Flexible Cystoscope to clinical outcomes associated with reusable cystoscopes