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Per the applicant, the LithoVue TM Elite System consists of a single-use, disposable flexible ureteroscope (the LithoVue TM Elite Ureteroscope) and a workstation (the StoneSmart Connect Console), that provide real-time intraluminal pressure monitoring in the kidney and ureter during ureteroscopy and can be used in conjunction with endoscopic accessories to perform various diagnostic and therapeutic procedures in the urinary tract