The following data is part of a premarket notification filed by Creo Medical Ltd with the FDA for Creo Medical Electrosurgical System Including Speedboat Rs2 Surgical Accessory.
| Device ID | K171983 |
| 510k Number | K171983 |
| Device Name: | Creo Medical Electrosurgical System Including Speedboat RS2 Surgical Accessory |
| Classification | Unit, Electrosurgical, Endoscopic (with Or Without Accessories) |
| Applicant | Creo Medical Ltd Riverside Court, Beaufort Park Chepstow, GB Np16 5uh |
| Contact | Keith Penny |
| Correspondent | Keith Penny Creo Medical Ltd. Riverside Court, Beaufort Park Chepstow, GB Np16 5uh |
| Product Code | KNS |
| CFR Regulation Number | 876.4300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-06-30 |
| Decision Date | 2017-08-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05060359560124 | K171983 | 000 |
| 05060359560087 | K171983 | 000 |
| 05060359560063 | K171983 | 000 |
| 05060359560025 | K171983 | 000 |
| 05060359560070 | K171983 | 000 |
| 05060359560292 | K171983 | 000 |
| 05060359560599 | K171983 | 000 |