FGD · Class II · 21 CFR 876.5980

FDA Product Code FGD: Catheter, Retention, Barium Enema With Bag

Leading manufacturers include E-Z-Em, Inc. and Chess Medical, Inc..

6
Total
6
Cleared
166d
Avg days
1987
Since
Declining activity - 0 submissions in the last 2 years vs 1 in the prior period

FDA 510(k) Cleared Catheter, Retention, Barium Enema With Bag Devices (Product Code FGD)

6 devices
1–6 of 6
Cleared Jun 16, 2023
NAJA Gastrointestinal Catheter
K223890
Chess Medical, Inc.
Gastroenterology & Urology · 171d
Cleared Jan 24, 1991
SLIM LINE RETENTION TIP W/ SILICONE RUBBER CUFF
K905574
E-Z-Em, Inc.
Gastroenterology & Urology · 43d
Cleared Nov 27, 1990
SLIM LINE RETENT TIP W/SILICONE INFLATION CUFF
K904299
E-Z-Em, Inc.
Gastroenterology & Urology · 69d

About Product Code FGD - Regulatory Context

510(k) Submission Activity

6 total 510(k) submissions under product code FGD since 1987, with 6 receiving FDA clearance (average review time: 166 days).

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