Recognized a 510(k)/PMA number — showing its clearance record and devices.
Devices
| Brand | Model | Company | Product codes | Primary DI |
|---|---|---|---|---|
| EndoSheath Technology | BF-0 | COGENTIX MEDICAL, INC. | EOQ | 00874485003050 |
| EndoSheath Technology | BV-0 | COGENTIX MEDICAL, INC. | EOQ | 00874485003098 |
| EndoSheath Technology | BVX-2.1 | COGENTIX MEDICAL, INC. | EOQ | 00874485003104 |
| EndoSheath Technology | BF-1.5 | COGENTIX MEDICAL, INC. | EOQ | 00874485003036 |
| EndoSheath Technology | BVX-2.8 | COGENTIX MEDICAL, INC. | EOQ | 00874485003128 |
| EndoSheath Technology | BF-2.1 | COGENTIX MEDICAL, INC. | EOQ | 00874485003029 |
| EndoSheath Technology | BVX-1.5 | COGENTIX MEDICAL, INC. | EOQ | 00874485003111 |
| EndoSheath Technology | BF-2.8 | COGENTIX MEDICAL, INC. | EOQ | 00874485003043 |
| EndoSheath Technology | BVX-0 | COGENTIX MEDICAL, INC. | EOQ | 00874485003135 |
| EndoSheath Technology | BV-1.5 | COGENTIX MEDICAL, INC. | EOQ | 00874485003074 |
| EndoSheath Technology | BV-2.1 | COGENTIX MEDICAL, INC. | EOQ | 00874485003067 |