K223926
- 510(k) number
- K223926
- Device name
- VersaVue Single-Use Flexible Cystoscope, VersaVue Tablet, and VersaVue Video Box
- Applicant
- Medimaging Integrated Solution, Inc (Miis) CN
- Product code
- FAJ — Cystoscope And Accessories, Flexible/Rigid
- Decision date
- 2023-10-06
- Date received
- 2022-12-30
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Gastroenterology, Urology
510(k) Summary (official FDA PDF): K223926.pdf
Official FDA record: K223926
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.