Product code FGD— Gastroenterology, Urology

FDA has cleared 6 devices under product code FGD between 1987 and 2023, filed by 5 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.

• 20231 clearance
• 19912 clearances
• 19901 clearance
• 19891 clearance
• 19871 clearance

• E-Z-Em, Inc.2 clearances
• Mmi, Inc.1 clearance
• Mac Lee Medical Products1 clearance
• Lafayette Pharmacal, Inc.1 clearance
• Chess Medical, Inc.1 clearance

• K223890 — NAJA Gastrointestinal CatheterChess Medical, Inc.·2023-06-16
• K905026 — DUAL FLEX NON-LATEXMmi, Inc.·1991-12-18
• K905574 — SLIM LINE RETENTION TIP W/ SILICONE RUBBER CUFFE-Z-Em, Inc.·1991-01-24
• K904299 — SLIM LINE RETENT TIP W/SILICONE INFLATION CUFFE-Z-Em, Inc.·1990-11-27
• K884379 — MAGLINTE ENTEROCLYSIS CATHETERLafayette Pharmacal, Inc.·1989-02-28
• K872006 — DISPOSABLE BARIUM ENEMA TIP WITH RETENTION CUFFMac Lee Medical Products·1987-11-17