FAN
- Product code
- FAN
- Device name
- Sigmoidoscope, Rigid, Electrical
- Device class
- Class 2
- 21 CFR
- 21 CFR 876.1500
- Medical specialty
- Gastroenterology, Urology
- Marketing pathway
- 510(K)
- 510(k) clearances (last 3 years)
- 1
- Summaries archived here
- 1 (direct download)
- 510(k) clearances (all years, FDA)
- 2 (all years; only the last 3 years are listed here)
510(k) clearances, last 3 years (1)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K232262 | 2023-11-30 | Surgease Innovations Limited | LumenEye® X1 endoscope (LX1-SCP-203); LumenEye® X1 c… |
Official FDA classification page: FAN
Classification and pathway per current FDA publications. Data from openFDA (CC0).