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This strategy is further integrated with anti-cancer immunotherapy to improve treatment outcomes [312]

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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