Panels › Gastroenterology, Urology › Product code FGD · Class 2
Catheter, Retention, Barium Enema With Bag
Regulation 876.5980
0510(k)s in 12 months (6 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in FGD
| Company | 510(k)s | Recalls |
|---|---|---|
| E-Z-Em, Inc. | 2 | 0 |
| Chess Medical, Inc. | 1 | 0 |
| Lafayette Pharmacal, Inc. | 1 | 0 |
| Mac Lee Medical Products | 1 | 0 |
| Mmi, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jun 16, 2023 | K223890 | NAJA Gastrointestinal Catheter Chess Medical, Inc., CA | FGD |
| Dec 18, 1991 | K905026 | DUAL FLEX NON-LATEX Mmi, Inc. | FGD |
| Jan 24, 1991 | K905574 | SLIM LINE RETENTION TIP W/ SILICONE RUBBER CUFF E-Z-Em, Inc. | FGD |
| Nov 27, 1990 | K904299 | SLIM LINE RETENT TIP W/SILICONE INFLATION CUFF E-Z-Em, Inc. | FGD |
| Feb 28, 1989 | K884379 | MAGLINTE ENTEROCLYSIS CATHETER Lafayette Pharmacal, Inc. | FGD |
| Nov 17, 1987 | K872006 | DISPOSABLE BARIUM ENEMA TIP WITH RETENTION CUFF Mac Lee Medical Products | FGD |
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