K171983 is an FDA 510(k) clearance for the Creo Medical Electrosurgical System including Speedboat RS2 Surgical Accessory. This device is classified as a Unit, Electrosurgical, Endoscopic (with Or Without Accessories) (Class II - Special Controls, product code KNS).
Submitted by Creo Medical, Ltd. (Chepstow, GB). The FDA issued a Cleared decision on August 17, 2017, 48 days after receiving the submission on June 30, 2017.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.4300.
| 510(k) Number | K171983 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 30, 2017 |
| Decision Date | August 17, 2017 |
| Days to Decision | 48 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | KNS - Unit, Electrosurgical, Endoscopic (with Or Without Accessories) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.4300 |