K242535
- 510(k) number
- K242535
- Device name
- Single-use Flexible Cystoscope (CY-E2E01, CY-E2E01R, CY-E2F01, CY-E2F01R, CY-E2G01, CY-E2G01R, CY-S2E01, CY-S2E01R); Digital Video Monitor (DVM-D1, DVM-D2)
- Applicant
- Hunan Vathin Medical Instrument Co., Ltd. CN
- Product code
- FAJ — Cystoscope And Accessories, Flexible/Rigid
- Decision date
- 2024-12-18
- Date received
- 2024-08-26
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Gastroenterology, Urology
510(k) Summary (official FDA PDF): K242535.pdf
Official FDA record: K242535
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.