FAN · Class II · 21 CFR 876.1500

FDA Product Code FAN: Sigmoidoscope, Rigid, Electrical

Leading manufacturers include Surgease Innovations Limited and C.R. Bard, Inc..

2
Total
2
Cleared
112d
Avg days
1983
Since
Declining activity - 0 submissions in the last 2 years vs 1 in the prior period

FDA 510(k) Cleared Sigmoidoscope, Rigid, Electrical Devices (Product Code FAN)

2 devices
1–2 of 2
Cleared Nov 30, 2023
LumenEye® X1 endoscope (LX1-SCP-203)
K232262
Surgease Innovations Limited
Gastroenterology & Urology · 122d
Cleared Sep 12, 1983
URODYNAMIC ANALYZER
K831788
C.R. Bard, Inc.
Gastroenterology & Urology · 101d

About Product Code FAN - Regulatory Context

510(k) Submission Activity

2 total 510(k) submissions under product code FAN since 1983, with 2 receiving FDA clearance (average review time: 112 days).

Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 1 in the prior period.