Recognized a 510(k)/PMA number — showing its clearance record and devices.
Devices
| Brand | Model | Company | Product codes | Primary DI |
|---|---|---|---|---|
| ATEC SAPPHIRE | ATEC SAPPHIRE | Hologic, Inc. | KNW | 15420045504295 |
| Eviva Needle Guide | EVIVA_NG09L | Hologic, Inc. | KNW | 05420045503710 |
| ATEC SAPPHIRE 100 | ATEC SAPPHIRE 100 | Hologic, Inc. | KNW | 15420045504028 |
| ATEC Sapphire 200 | ATEC Sapphire 200 | Hologic, Inc. | KNW | 15420045504110 |
| Eviva Needle Guide | EVIVA_NG09R | Hologic, Inc. | KNW | 15420045504608 |
| ATEC 0914-12MR | ATEC 0914-12MR | Hologic, Inc. | KNW | 15420045504875 |
| ATEC Needle Guide | ATEC_NG09-A2 | Hologic, Inc. | KNW | 05420045503154 |
| ATEC 0909-12 | ATEC 0909-12 | Hologic, Inc. | KNW | 15420045504837 |
| ATEC 0912-20 | ATEC 0912-20 | Hologic, Inc. | KNW | 15420045504868 |
| ATEC Introducer | ILS 0914-12 | Hologic, Inc. | KNW | 05420045503192 |
| ATEC 0914-20 | ATEC 0914-20 | Hologic, Inc. | KNW | 15420045504882 |
| ATEC | ATEC Canister | Hologic, Inc. | KNW | 15420045503182 |
| ATEC 0909-20 | ATEC 0909-20 | Hologic, Inc. | KNW | 15420045504844 |
| ATEC 1212-20 | ATEC 1212-20 | Hologic, Inc. | KNW | 15420045504912 |
| Eviva Needle Guide | EVIVA_NG12L | Hologic, Inc. | KNW | 05420045503734 |
| ATEC PEARL | ATEC PEARL | Hologic, Inc. | KNW | 15420045506855 |
| ATEC 1209-20 | ATEC 1209-20 | Hologic, Inc. | KNW | 15420045504905 |
| ATEC 0912-12 | ATEC 0912-12 | Hologic, Inc. | KNW | 15420045504851 |
| ATEC Introducer | ILS 0914-12-OB | Hologic, Inc. | KNW | 05420045503796 |
| ATEC | ATEC TF-1 | Hologic, Inc. | KNW | 05420045503161 |
| ATEC Introducer | ILS 0914-20-OB | Hologic, Inc. | KNW | 05420045503789 |
| Eviva Needle Guide | EVIVA_NG12R | Hologic, Inc. | KNW | 15420045504615 |
| ATEC Introducer | ILS 0914-20 | Hologic, Inc. | KNW | 05420045503208 |
| ATEC 0914-20MR | ATEC 0914-20MR | Hologic, Inc. | KNW | 15420045504899 |
| ATEC EMERALD | ATEC EMERALD | Hologic, Inc. | KNW | 15420045506848 |