Recognized a 510(k)/PMA number — showing its clearance record and devices.
Clearance record K242535
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) · Hunan Vathin Medical Instrument Co., Ltd. · decided 2024-12-18 (SESE)
Devices
| Brand | Model | Company | Product codes | Primary DI |
|---|---|---|---|---|
| Single-Use Flexible Cystoscope | CY-E2E01 | Hunan Vathin Medical Instrument Co., Ltd | FAJ | 06972197482386 |
| Single-Use Flexible Cystoscope | CY-E2F01 | Hunan Vathin Medical Instrument Co., Ltd | FAJ | 06972197482409 |
| Single-Use Flexible Cystoscope | CY-E2G01R | Hunan Vathin Medical Instrument Co., Ltd | FAJ | 06972197483154 |
| Single-Use Flexible Cystoscope | CY-S2E01R | Hunan Vathin Medical Instrument Co., Ltd | FAJ | 06972197483376 |
| Single-Use Flexible Cystoscope | CY-S2E01 | Hunan Vathin Medical Instrument Co., Ltd | FAJ | 06972197482393 |
| Single-Use Flexible Cystoscope | CY-E2G01 | Hunan Vathin Medical Instrument Co., Ltd | FAJ | 06972197482423 |
| Single-Use Flexible Cystoscope | CY-E2F01R | Hunan Vathin Medical Instrument Co., Ltd | FAJ | 06972197483161 |
| Single-Use Flexible Cystoscope | CY-E2E01R | Hunan Vathin Medical Instrument Co., Ltd | FAJ | 06972197483147 |