FDA product code FEG: Tube, Double Lumen For Intestinal Decompression And/Or Intubation
FEG is the FDA product code for tube, double lumen for intestinal decompression and/or intubation. It is a Class II device, regulated under 21 CFR 876.5980 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 13 510(k) submissions under FEG, from 12 different applicants. The average 510(k) review took 190 days (median 87). FDA has posted 14 recalls for FEG devices, 13 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Tube, Double Lumen For Intestinal Decompression And/Or Intubation |
| Device class | Class II |
| Regulation | 21 CFR 876.5980 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for FEG
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 60 |
Compare with all 510(k) review times · Search every FEG clearance
Top FEG applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Kendall | 2 | 2006-01-06 |
| Cook Ireland, Ltd. | 1 | 2017-08-01 |
| Medline Industries, Inc. | 1 | 2013-09-18 |
| Michael M. Knott, M.D. | 1 | 1997-11-19 |
| C.R. Bard, Inc. | 1 | 1996-07-24 |
7 more applicants have FEG clearances. See the full list in Caduvo.
Most recent FEG clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K171619 | Cook Ireland, Ltd. | 14Fr Colon Decompression Set, Macon Colon Decompression Set | 2017-08-01 | 60 |
| K132314 | Medline Industries, Inc. | MEDLINE ANTI-REFLUX VALVE | 2013-09-18 | 55 |
| K053410 | Kendall | GIENTRIPORT WITH UNIVERSAL SINGLE LUMEN ADAPTOR | 2006-01-06 | 30 |
| K040388 | Kendall | NEXT GENERATION SALEM SUMP | 2004-05-17 | 90 |
| K971354 | Michael M. Knott, M.D. | KNOTT NG TUBE | 1997-11-19 | 222 |
Recalls for FEG devices
14 product recalls in 4 recall events; 13 initiated in the last five years and 13 still open. Most recent: 2025-09-18.
| Year | Recalls |
|---|---|
| 2023 | 10 |
| 2024 | 1 |
| 2025 | 2 |
Frequently asked questions
What is FDA product code FEG?
FEG is the FDA product code for tube, double lumen for intestinal decompression and/or intubation. It is a Class II device, regulated under 21 CFR 876.5980 and reviewed by the Gastroenterology and Urology panel.
What device class is FEG?
Class II, regulation 21 CFR 876.5980. Typical premarket route: 510(k).
How long does a 510(k) take for product code FEG?
Across 13 cleared submissions the average was 190 days from receipt to decision (median 87).
Which companies have the most FEG clearances?
Kendall (2); Cook Ireland, Ltd. (1); Medline Industries, Inc. (1); Michael M. Knott, M.D. (1); C.R. Bard, Inc. (1).
Have FEG devices been recalled?
Yes: 14 product recalls across 4 recall events; the most recent began 2025-09-18.
Next steps
- Run an FDA pathway report with predicate devices for product code FEG
- Run a recall and safety report across every FEG manufacturer
- Watch product code FEG 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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