The following data is part of a premarket notification filed by Creo Medical Ltd. with the FDA for Np1 Instrument, Creo Electrosurgical System.
| Device ID | K200003 |
| 510k Number | K200003 |
| Device Name: | NP1 Instrument, Creo Electrosurgical System |
| Classification | System, Ablation, Microwave And Accessories |
| Applicant | Creo Medical Ltd. Creo House, Unit 2, Beaufort Park Way Chepstow, GB Np16 5uh |
| Contact | Shaun Preston |
| Correspondent | Phil Triolo Phil Triolo And Associates LC 86 Skycrest Ln Salt Lake City, UT 84108 |
| Product Code | NEY |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-01-02 |
| Decision Date | 2020-10-28 |