FDA.reportPublic FDA data

Intraurethral valve/pump

Definition
A sterile, non-powered device intended to be inserted into the female urethra to facilitate urine voiding in patients with incomplete bladder emptying due to impaired detrusor contractility (IDC) of neurologic origin. It is a tube, held in place at the bladder neck, containing a pump and valve. Its function as a pump to achieve urinary voiding, and as a valve to prevent urine leakage (incontinence) between voids, is controlled by a battery-powered, magnetically-coupled remote control. This is a single-patient device intended to be left in situ for up to 29 days before being discarded (single-use) and replaced.
GUDID devices
19
Last updated
2021-09-06 09:29:46

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00862563003078inFlow Sizing DeviceVESIFLO INCMarch 20172021-08-28
00862563003085inFlow DeviceVESIFLO INCMarch 20172021-08-28
00862563003092inFlow DeviceVESIFLO INCMarch 20172021-08-28
00862563003108inFlow DeviceVESIFLO INCMarch 20172021-08-28
00862563003115inFlow DeviceVESIFLO INCMarch 20172021-08-28
00862563003122inFlow DeviceVESIFLO INCMarch 20172021-08-28
00862563003139inFlow DeviceVESIFLO INCMarch 20172021-08-28
00862563003146inFlow DeviceVESIFLO INCMarch 20172021-08-28
00862563003153ActivatorVESIFLO INCAugust 20212021-08-28
00862563003160Base StationVESIFLO INCAugust 20212021-08-28
00862563003177Medical ChargerVESIFLO INCAugust 20212021-08-28
00862563003184Activator KitVESIFLO INCAugust 20212021-08-28
00862563003191Magnetic ShieldVESIFLO INCAugust 20212021-08-28
08625630003003inFlow Intraurethral Valve-PumpVESIFLO INCSep 20162016-10-24
08625630003034inFlow Intraurethral Valve-PumpVESIFLO INCSep 20162016-12-07
08625630003001ActivatorVESIFLO INCSep 20162016-09-19
08625630003002inFlow Intraurethral Valve-PumpVESIFLO INCSep 20162016-09-20
08625630003010ActivatorVESIFLO INCSep 20162016-12-08
08625630003027inFlow Intraurethral Valve-PumpVESIFLO INCSep 20162016-12-07