Recognized a 510(k)/PMA number — showing its clearance record and devices.
Clearance record K242575
Stereotaxic Guiding Surgical Devices, NaoTrac S · Brain Navi Biotechnology Co., Ltd. · decided 2025-05-23 (SESE)
Devices
| Brand | Model | Company | Product codes | Primary DI |
|---|---|---|---|---|
| Instrument Holder S Set | FPIH1172 | BRAIN NAVI BIOTECHNOLOGY CO., LTD. | HAW | 04719878696029 |
| Instrument Adaptor (6.4 mm) | COIH030E | BRAIN NAVI BIOTECHNOLOGY CO., LTD. | HAW | 04719878695442 |
| Instrument Adaptor (6 mm) | COIH030D | BRAIN NAVI BIOTECHNOLOGY CO., LTD. | HAW | 04719878695428 |
| Instrument Adaptor (4.6 mm) | COIH030B | BRAIN NAVI BIOTECHNOLOGY CO., LTD. | HAW | 04719878695381 |
| Instrument Adaptor (3.5 mm) | COIH030A | BRAIN NAVI BIOTECHNOLOGY CO., LTD. | HAW | 04719878695367 |
| Instrument Adaptor (2.2 mm) | COIH0306 | BRAIN NAVI BIOTECHNOLOGY CO., LTD. | HAW | 04719878695282 |
| Catheter Adaptor_3.5mm | FPIH0402 | BRAIN NAVI BIOTECHNOLOGY CO., LTD. | HAW | 04719878695220 |
| Catheter Adaptor | FPIH0401 | BRAIN NAVI BIOTECHNOLOGY CO., LTD. | HAW | 04719878695145 |
| SEEG Adaptor | FPIH0310 | BRAIN NAVI BIOTECHNOLOGY CO., LTD. | HAW | 04719878695121 |
| Instrument Adaptor (8 mm) | COIH0304 | BRAIN NAVI BIOTECHNOLOGY CO., LTD. | HAW | 04719878695107 |
| Instrument Adaptor (5 mm) | COIH0303 | BRAIN NAVI BIOTECHNOLOGY CO., LTD. | HAW | 04719878695084 |
| Instrument Adaptor (4 mm) | COIH0302 | BRAIN NAVI BIOTECHNOLOGY CO., LTD. | HAW | 04719878695060 |
| Instrument Registration Platform Cover | FPIR0211 | BRAIN NAVI BIOTECHNOLOGY CO., LTD. | HAW | 04719878694001 |
| Power Supply Cord (US) 5m | COWI0206 | BRAIN NAVI BIOTECHNOLOGY CO., LTD. | HAW | 04719878691468 |
| Display Screen | CODS0001 | BRAIN NAVI BIOTECHNOLOGY CO., LTD. | HAW | 04719878691246 |
| Foot Controller | COFP1000 | BRAIN NAVI BIOTECHNOLOGY CO., LTD. | HAW | 04719878691208 |
| Nao Trac S | FPNT0201 | BRAIN NAVI BIOTECHNOLOGY CO., LTD. | HAW | 04719878691024 |
| Basic Sterilization Case Set | OPCA1491 | BRAIN NAVI BIOTECHNOLOGY CO., LTD. | HAW | 04719878695480 |
| Instrument Adaptor (7 mm) | COIH030F | BRAIN NAVI BIOTECHNOLOGY CO., LTD. | HAW | 04719878695466 |
| Instrument Adaptor (5.2 mm) | COIH030C | BRAIN NAVI BIOTECHNOLOGY CO., LTD. | HAW | 04719878695404 |
| Instrument Adator (3.2 mm) | COIH0309 | BRAIN NAVI BIOTECHNOLOGY CO., LTD. | HAW | 04719878695343 |
| Instrument Adaptor (2.8 mm) | COIH0308 | BRAIN NAVI BIOTECHNOLOGY CO., LTD. | HAW | 04719878695329 |
| Instrument Adaptor (2.5 mm) | COIH0307 | BRAIN NAVI BIOTECHNOLOGY CO., LTD. | HAW | 04719878695305 |
| Instrument Adaptor (2 mm) | COIH0305 | BRAIN NAVI BIOTECHNOLOGY CO., LTD. | HAW | 04719878695268 |
| Instrument Adaptor (1.8 mm) | COIH0300 | BRAIN NAVI BIOTECHNOLOGY CO., LTD. | HAW | 04719878695244 |