FDA Product Code
FDA Product Code FGD — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Gastroenterology, Urology
- 21 CFR Citation
- 876.5980
510(k) Clearances — 6 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K223890 | NAJA Gastrointestinal Catheter | Chess Medical, Inc. | 2023-06-16 | Traditional | PDF ↗ |
| K905026 | DUAL FLEX NON-LATEX | Mmi, Inc. | 1991-12-18 | Traditional | PDF ↗ |
| K905574 | SLIM LINE RETENTION TIP W/ SILICONE RUBBER CUFF | E-Z-Em, Inc. | 1991-01-24 | Traditional | PDF ↗ |
| K904299 | SLIM LINE RETENT TIP W/SILICONE INFLATION CUFF | E-Z-Em, Inc. | 1990-11-27 | Traditional | PDF ↗ |
| K884379 | MAGLINTE ENTEROCLYSIS CATHETER | Lafayette Pharmacal, Inc. | 1989-02-28 | Traditional | PDF ↗ |
| K872006 | DISPOSABLE BARIUM ENEMA TIP WITH RETENTION CUFF | Mac Lee Medical Products | 1987-11-17 | Traditional | PDF ↗ |
Product code FGD · Class II · Gastroenterology, Urology. Data: openFDA.