FEGClass II
Tube, Double Lumen For Intestinal Decompression And/Or Intubation
21 CFR 876.5980 / Gastroenterology, Urology
FEG is the FDA product code for Tube, Double Lumen For Intestinal Decompression And/Or Intubation, a class II device type, regulated under 21 CFR 876.5980. As of , FDA records hold 13 510(k) clearances under this code, the most recent dated , and 14 recalls.
Classification record
- Product code
- FEG
- Device name
- Tube, Double Lumen For Intestinal Decompression And/Or Intubation
- Regulation
- 21 CFR 876.5980
- Device class
- Class II
- Review panel
- Gastroenterology, Urology
- Submission type
- 510(k)
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- Yes
- Ingested clearances
- 13
- Ingested recalls
- 14
Clearances, product code FEG
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 1977 | 1 |
| 1978 | 1 |
| 1988 | 1 |
| 1990 | 1 |
| 1992 | 1 |
| 1995 | 2 |
| 1996 | 1 |
| 1997 | 1 |
| 2004 | 1 |
| 2006 | 1 |
| 2013 | 1 |
| 2017 | 1 |
Applicants with the most clearances
Product code FEG| Applicant | Clearances |
|---|---|
| Kendall | 2 |
| Axiom Medical, Inc. | 1 |
| C.R. Bard Inc | 1 |
| Cook Ireland Ltd. | 1 |
| Abbott Medical | 1 |
| Kmb Medical Products Co. | 1 |
| Mallinckrodt Critical Care | 1 |
| MEDLINE INDUSTRIES, LP - Northfield | 1 |
| Michael M. Knott, M.D. | 1 |
| Sherwood Medical Co. | 1 |
Companies listing this code with FDA
Companies whose registered establishments list this code- Allwin Medical Devices, Inc.
- Axiom Medical, Inc.
- C.R. Bard Inc
- Cardinal Health (Kenmex Medical Specialties)
- Cardinal Health C/O Avarto Benelux BV
- Convertors de Mexico S. de R.L. de C.V
- Cook Ireland Ltd.
- Cook Medical EUDC GmbH
- Cook Medical LLC
- DeRoyal Industries, Inc.
- Isomedix Operations Inc
- Jiangsu Caina Medical Co., Ltd
FIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.