Product code FAN— Gastroenterology, Urology
LumenEye® X1 endoscope (LX1-SCP-203) +2 more
- Classification name
- Sigmoidoscope, Rigid, Electrical
- Device class
- Class 2
- Regulation
- 21 CFR 876.1500
- Advisory panel
- Gastroenterology, Urology
- Total cleared
- 2
- First cleared
- Most recent
Market context for product code FAN
FDA has cleared devices under product code FAN between 1983 and 2023, filed by 2 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
- 2023
- 1983
Top applicants under product code FAN
Recent clearances under product code FAN
Data sourced from openFDA. This site is unofficial and independent of the FDA.