Device Dossier
Flexible video cystoscope, single-use
Device Dossier for Flexible video cystoscope, single-use (Flexible video cystoscope, single-use, Class IIa, sponsor Emergo). ARTG record, intended…
- GMDN category: Flexible video cystoscope, single-use
Intended purpose
Intended purpose: The BubbleView Single-Use Digital Flexible Cystoscope is a sterile, single-use, flexible endoscope intended to be used for the examination, diagnosis, and treatment of the urethra, bladder, and renal pelvis (percutaneous). The BubbleView is intended to provide visualization via ViewHub video processor and can be used with endoscopic accessories. Medical indication: Endoscopy within the urethra, bladder, and renal pelvis. Intended user: The device is intended to be used by professional. Intended patient population: Adult (including elderly person). Patient selection criteria: patient over 18 years of age. Intended use environment: The endoscope is intended for use in a hospital environment and medical office environment.