Recognized a 510(k)/PMA number — showing its clearance record and devices.
Devices
| Brand | Model | Company | Product codes | Primary DI |
|---|---|---|---|---|
| EndoSheath Technology | CV-1.5 | COGENTIX MEDICAL, INC. | FAJ | 00874485003173 |
| Video Processor | DPU-7000A | COGENTIX MEDICAL, INC. | FAJ | 00874485002572 |
| Flexible Video Cystoscope (NTSC) | CST-5000 | COGENTIX MEDICAL, INC. | FAJ | 00874485000882 |
| Video Processor | DPU-5050A | COGENTIX MEDICAL, INC. | FAJ | 00874485002565 |
| Flexible Video Cystoscope (NTSC) Intuitive | CST-5000iS | COGENTIX MEDICAL, INC. | FAJ | 00874485002978 |
| Flexible Video Cystoscope (NTSC) Intuitive | CST-5000i | COGENTIX MEDICAL, INC. | FAJ | 00874485001278 |
| Video Processor | DPU-5050A | COGENTIX MEDICAL, INC. | FAJ | 00874485000943 |
| Video Processor | DPU-7000A | COGENTIX MEDICAL, INC. | FAJ | 00874485002275 |
| Flexible Video Cystoscope (NTSC) Intuitive Reconditioned | CST-5000i | COGENTIX MEDICAL, INC. | FAJ | 00874485002824 |
| EndoSheath Technology | CV-2.1 | COGENTIX MEDICAL, INC. | FAJ | 00874485003166 |
| Flexible Video Cystoscope (NTSC) | CST-5000S | COGENTIX MEDICAL, INC. | FAJ | 00874485002961 |
| Flexible Video Cystoscope (NTSC) Reconditioned | CST-5000 | COGENTIX MEDICAL, INC. | FAJ | 00874485002800 |