Product Code: FGD FDA class 2 21 CFR 876.5980

Catheter, Retention, Barium Enema With Bag

Gastroenterology, Urology

The Barium Enema Retention Catheter with Bag is a device used during radiological contrast enema procedures to introduce and retain barium sulfate suspension within the colon for fluoroscopic imaging. It is classified as FDA Class 2, indicating moderate risk and requiring 510(k) premarket notification. The product code is FGD, regulated under 21 CFR 876.5980, within the Gastroenterology, Urology medical specialty.

View on FDA

510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

Research product code FGD in seconds

The Research Assistant summarizes clearances, adverse event trends and regulation context for a product code — and cites every record.

Free to try · every answer cites its records

Ask the Research Assistant See examples

Basic Information

Product Code: FGD
Device Class: FDA class 2
Regulation Number: 876.5980
Medical Specialty: Gastroenterology, Urology
Review Panel: GU
Submission Type: 4

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✗

Third Party

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 6 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K223890	NAJA Gastrointestinal Catheter	Jun 16, 2023	Substantially Equivalent	Chess Medical, Inc.
K905026	DUAL FLEX NON-LATEX	Dec 18, 1991	Substantially Equivalent	Mmi, Inc.
K905574	SLIM LINE RETENTION TIP W/ SILICONE RUBBER CUFF	Jan 24, 1991	Substantially Equivalent	E-Z-Em, Inc.
K904299	SLIM LINE RETENT TIP W/SILICONE INFLATION CUFF	Nov 27, 1990	Substantially Equivalent	E-Z-Em, Inc.
K884379	MAGLINTE ENTEROCLYSIS CATHETER	Feb 28, 1989	Substantially Equivalent	Lafayette Pharmacal, Inc.
K872006	DISPOSABLE BARIUM ENEMA TIP WITH RETENTION CUFF	Nov 17, 1987	Substantially Equivalent	Mac Lee Medical Products