FDA product code FGD: Catheter, Retention, Barium Enema With Bag
FGD is the FDA product code for catheter, retention, barium enema with bag. It is a Class II device, regulated under 21 CFR 876.5980 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 6 510(k) submissions under FGD, 1 in the last five years, from 5 different applicants. The average 510(k) review took 166 days (median 152).
Classification
| Field | Value |
|---|---|
| Device name | Catheter, Retention, Barium Enema With Bag |
| Device class | Class II |
| Regulation | 21 CFR 876.5980 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) exempt |
510(k) clearances per year for FGD
| Year | Clearances | Avg. review days |
|---|---|---|
| 2023 | 1 | 171 |
Compare with all 510(k) review times · Search every FGD clearance
Top FGD applicants
| Applicant | Clearances | Latest |
|---|---|---|
| E-Z-Em, Inc. | 2 | 1991-01-24 |
| Chess Medical, Inc. | 1 | 2023-06-16 |
| Mmi, Inc. | 1 | 1991-12-18 |
| Lafayette Pharmacal, Inc. | 1 | 1989-02-28 |
| Mac Lee Medical Products | 1 | 1987-11-17 |
Most recent FGD clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K223890 | Chess Medical, Inc. | NAJA Gastrointestinal Catheter | 2023-06-16 | 171 |
| K905026 | Mmi, Inc. | DUAL FLEX NON-LATEX | 1991-12-18 | 406 |
| K905574 | E-Z-Em, Inc. | SLIM LINE RETENTION TIP W/ SILICONE RUBBER CUFF | 1991-01-24 | 43 |
| K904299 | E-Z-Em, Inc. | SLIM LINE RETENT TIP W/SILICONE INFLATION CUFF | 1990-11-27 | 69 |
| K884379 | Lafayette Pharmacal, Inc. | MAGLINTE ENTEROCLYSIS CATHETER | 1989-02-28 | 133 |
Recalls for FGD devices
openFDA lists no recalls for product code FGD.
Frequently asked questions
What is FDA product code FGD?
FGD is the FDA product code for catheter, retention, barium enema with bag. It is a Class II device, regulated under 21 CFR 876.5980 and reviewed by the Gastroenterology and Urology panel.
What device class is FGD?
Class II, regulation 21 CFR 876.5980. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code FGD?
Across 6 cleared submissions the average was 166 days from receipt to decision (median 152).
Which companies have the most FGD clearances?
E-Z-Em, Inc. (2); Chess Medical, Inc. (1); Mmi, Inc. (1); Lafayette Pharmacal, Inc. (1); Mac Lee Medical Products (1).
Next steps
- Run an FDA pathway report with predicate devices for product code FGD
- Run a recall and safety report across every FGD manufacturer
- Watch product code FGD for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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