Clearance Summary
VersaVue Single-Use Flexible Cystoscope, VersaVue Tablet, and VersaVue Video Box received FDA 510(k) clearance under submission number K223926, sponsored by Medimaging Integrated Solution, Inc (Miis). The device was reviewed via the Traditional premarket notification pathway and assigned to the Gastroenterology, Urology review panel. The statutory decision date of record is 2023-10-06.
- Submission: K223926
- Applicant / Sponsor: Medimaging Integrated Solution, Inc (Miis)
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.1500
- Decision date: 2023-10-06
Classification & Regulation
This clearance is catalogued under FDA product code FAJ and 21 CFR 876.1500, within the Gastroenterology, Urology review panel as a Class II device.