FGD — Catheter, Retention, Barium Enema With Bag Class II
FDA product code FGD covers "Catheter, Retention, Barium Enema With Bag", a Class II medical device regulated under 21 CFR 876.5980. Submissions are reviewed by the Gastroenterology, Urology panel. At least 6 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- FGD
- Device Class
- Class II
- Regulation Number
- 876.5980
- Submission Type
- Review Panel
- GU
- Medical Specialty
- Gastroenterology, Urology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K223890 | chess medical | NAJA Gastrointestinal Catheter | June 16, 2023 |
| K905026 | mmi | DUAL FLEX NON-LATEX | December 18, 1991 |
| K905574 | e-z-em | SLIM LINE RETENTION TIP W/ SILICONE RUBBER CUFF | January 24, 1991 |
| K904299 | e-z-em | SLIM LINE RETENT TIP W/SILICONE INFLATION CUFF | November 27, 1990 |
| K884379 | lafayette pharmacal | MAGLINTE ENTEROCLYSIS CATHETER | February 28, 1989 |
| K872006 | mac lee medical products | DISPOSABLE BARIUM ENEMA TIP WITH RETENTION CUFF | November 17, 1987 |