FEG
13 FDA 510(k) clearances · Product code
87 daysmedian time to decision
417 days90th percentile
13clearances measured
FDA profile
- Official device name
- Tube, Double Lumen For Intestinal Decompression And/Or Intubation
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5980
- Medical specialty
- Gastroenterology, Urology
- Flags
- Third-party review eligible
- Adverse events (MAUDE)
- 2021: 27 · 2022: 40 · 2023: 33 · 2024: 31 · 2025: 46 · 2026: 17
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| 14Fr Colon Decompression Set, Macon Colon Decompression Set (K171619) | Cook Ireland, Ltd. | 2017-08-01 |
| MEDLINE ANTI-REFLUX VALVE (K132314) | Medline Industries, Inc. | 2013-09-18 |
| GIENTRIPORT WITH UNIVERSAL SINGLE LUMEN ADAPTOR (K053410) | Kendall | 2006-01-06 |
| NEXT GENERATION SALEM SUMP (K040388) | Kendall | 2004-05-17 |
| KNOTT NG TUBE (K971354) | Michael M. Knott, M.D. | 1997-11-19 |
| DAVOL NASOGASTRIC SUMP TUBE W/PREVENT FILTER (K960176) | C.R. Bard, Inc. | 1996-07-24 |
| ULTRAVAC-NG(TM) NASOGASTRIC SUMP SUCTION TUBE (K926073) | Surgimark, Inc. | 1995-05-15 |
| ARGYLE SALEM SUMP TUBE ANTI-REFLUX VALVE INSERTION TRAY (K935781) | Sherwood Medical Co. | 1995-01-27 |
| LOPEZ VALVE WITH NG SUMP TUBE (K921104) | Icu Medical, Inc. | 1992-10-26 |
| WILSON-COOK COLON DECOMPRESSION SET (K900035) | Wilson-Cook Medical, Inc. | 1990-03-07 |
| KEITH NASOGASTRIC SUMP TUBE W/ANTI-REFLUX VALVE (K880850) | Kmb Medical Products Co. | 1988-05-26 |
| HODGE TUBE (K772282) | Mallinckrodt Critical Care | 1978-03-09 |
| CATHETERS, DRAINAGE (K771048) | Axiom Medical, Inc. | 1977-07-19 |
Track FEG automatically
Every clearance here is in the API, with alerts when new ones post.