The following data is part of a premarket notification filed by Creo Medical Ltd. with the FDA for Creo Electrosurgical System With Hs1 Hemostasis Accessory.
| Device ID | K192905 |
| 510k Number | K192905 |
| Device Name: | Creo Electrosurgical System With HS1 Hemostasis Accessory |
| Classification | Unit, Electrosurgical, Endoscopic (with Or Without Accessories) |
| Applicant | Creo Medical Ltd. Creo House, Unit 2, Beaufort Park Way Chepstow, GB Np16 5uh |
| Contact | Leif Geoghegan |
| Correspondent | Leif Geoghegan Phil Triolo And Associates LC 86 Skycrest Ln Salt Lake City, UT 84108 |
| Product Code | KNS |
| CFR Regulation Number | 876.4300 [🔎] |
| Decision | Substantially Equivalent - Kit (SESK) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-10-15 |
| Decision Date | 2020-03-19 |