FAN

Sigmoidoscope, Rigid, Electrical

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)

Last three years. Most recent: 2023-11-30.

NumberDecision dateApplicantDevice nameSummary
K2322622023-11-30Surgease Innovations LimitedLumenEye® X1 endoscope (LX1-SCP-203); LumenEye® X1 c…PDF

1 summaries are archived here for direct download.

Official FDA classification page: FAN
Classification and pathway per current FDA publications. Data from openFDA (CC0).