FAN — Sigmoidoscope, Rigid, Electrical Class II

FDA Device Classification

FDA product code FAN covers "Sigmoidoscope, Rigid, Electrical", a Class II medical device regulated under 21 CFR 876.1500. Submissions are reviewed by the Gastroenterology, Urology panel. At least 2 recent 510(k) clearances have been granted under this product code.

Classification Details

Product Code
FAN
Device Class
Class II
Regulation Number
876.1500
Submission Type
Review Panel
GU
Medical Specialty
Gastroenterology, Urology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K232262surgease innovations limitedLumenEye® X1 endoscope (LX1-SCP-203); LumenEye® X1 consumables (LX1-CSB-201); LNovember 30, 2023
K831788c.r. bardURODYNAMIC ANALYZERSeptember 12, 1983