K192905 is an FDA 510(k) clearance for the Creo Electrosurgical System with HS1 Hemostasis 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 March 19, 2020, 156 days after receiving the submission on October 15, 2019.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.4300.
| 510(k) Number | K192905 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Special 510(k) (SESK) |
| Date Received | October 15, 2019 |
| Decision Date | March 19, 2020 |
| Days to Decision | 156 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 |