K232262 is an FDA 510(k) clearance for the LumenEye® X1 endoscope (LX1-SCP-203). This device is classified as a Sigmoidoscope, Rigid, Electrical (Class II - Special Controls, product code FAN).
Submitted by Surgease Innovations Limited (Lancashire, GB). The FDA issued a Cleared decision on November 30, 2023, 122 days after receiving the submission on July 31, 2023.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.1500.
| 510(k) Number | K232262 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 31, 2023 |
| Decision Date | November 30, 2023 |
| Days to Decision | 122 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | FAN - Sigmoidoscope, Rigid, Electrical |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.1500 |