Product code FEG
- Device name
- Tube, Double Lumen For Intestinal Decompression And/Or Intubation
- Medical specialty
- Gastroenterology, Urology
- Device class
- 2
- Regulation number
- 876.5980
- Review panel
- GU
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K171619 | 14Fr Colon Decompression Set, Macon Colon Decompression Set | Cook Ireland, Ltd. | 2017-08-01 |
| K132314 | MEDLINE ANTI-REFLUX VALVE | Medline Industries, Inc. | 2013-09-18 |
| K053410 | GIENTRIPORT WITH UNIVERSAL SINGLE LUMEN ADAPTOR | Kendall | 2006-01-06 |
| K040388 | NEXT GENERATION SALEM SUMP | Kendall | 2004-05-17 |
| K971354 | KNOTT NG TUBE | Michael M. Knott, M.D. | 1997-11-19 |
| K960176 | DAVOL NASOGASTRIC SUMP TUBE W/PREVENT FILTER | C.R. Bard, Inc. | 1996-07-24 |
| K926073 | ULTRAVAC-NG(TM) NASOGASTRIC SUMP SUCTION TUBE | Surgimark, Inc. | 1995-05-15 |
| K935781 | ARGYLE SALEM SUMP TUBE ANTI-REFLUX VALVE INSERTION TRAY | Sherwood Medical Co. | 1995-01-27 |
| K921104 | LOPEZ VALVE WITH NG SUMP TUBE | Icu Medical, Inc. | 1992-10-26 |
| K900035 | WILSON-COOK COLON DECOMPRESSION SET | Wilson-Cook Medical, Inc. | 1990-03-07 |
| K880850 | KEITH NASOGASTRIC SUMP TUBE W/ANTI-REFLUX VALVE | Kmb Medical Products Co. | 1988-05-26 |
| K772282 | HODGE TUBE | Mallinckrodt Critical Care | 1978-03-09 |
| K771048 | CATHETERS, DRAINAGE | Axiom Medical, Inc. | 1977-07-19 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 10192253012484 | Salem Sump | Cardinal Health 200, LLC | 2026-03-19 |
| 10192253013009 | Salem Sump | Cardinal Health 200, LLC | 2026-03-19 |
| 10192253012989 | Salem Sump | Cardinal Health 200, LLC | 2026-03-19 |
| 10192253012521 | Salem Sump | Cardinal Health 200, LLC | 2026-03-19 |
| 10192253012507 | Salem Sump | Cardinal Health 200, LLC | 2026-03-19 |
| 10192253012460 | Salem Sump | Cardinal Health 200, LLC | 2026-03-19 |
| 10192253012767 | Salem Sump | Cardinal Health 200, LLC | 2026-01-16 |
| 10192253006889 | Salem Sump | Cardinal Health 200, LLC | 2026-01-16 |
| 10192253006902 | Salem Sump | Cardinal Health 200, LLC | 2026-01-16 |
| 10192253006872 | Salem Sump | Cardinal Health 200, LLC | 2026-01-16 |
| 10192253012842 | Salem Sump | Cardinal Health 200, LLC | 2024-01-19 |
| 10192253012781 | Salem Sump | Cardinal Health 200, LLC | 2024-01-19 |
| 10192253010145 | Salem Sump | Cardinal Health 200, LLC | 2023-12-06 |
| 10192253010091 | Salem Sump | Cardinal Health 200, LLC | 2023-12-06 |
| 10192253010626 | Salem Sump | Cardinal Health 200, LLC | 2023-11-30 |
| 10192253010183 | Salem Sump | Cardinal Health 200, LLC | 2023-11-30 |
| 10192253010381 | Salem Sump | Cardinal Health 200, LLC | 2023-11-30 |
| 10192253009873 | Kangaroo | Cardinal Health 200, LLC | 2023-11-16 |
| 10192253010169 | Salem Sump | Cardinal Health 200, LLC | 2023-11-06 |
| 10192253010121 | Salem Sump | Cardinal Health 200, LLC | 2023-10-30 |
| 10192253010411 | Salem Sump | Cardinal Health 200, LLC | 2023-10-30 |
| 10192253012828 | Salem Sump | Cardinal Health 200, LLC | 2023-10-27 |
| 10192253010077 | Salem Sump | Cardinal Health 200, LLC | 2023-10-25 |
| 10192253010213 | Salem Sump | Cardinal Health 200, LLC | 2023-10-25 |
| 10192253012804 | Salem Sump | Cardinal Health 200, LLC | 2023-10-23 |
| 10192253012774 | CARDINAL HEALTH | Cardinal Health 200, LLC | 2022-02-18 |
| 10192253012798 | CARDINAL HEALTH | Cardinal Health 200, LLC | 2022-02-18 |
| 10192253012811 | CARDINAL HEALTH | Cardinal Health 200, LLC | 2022-02-18 |
| 10192253012835 | CARDINAL HEALTH | Cardinal Health 200, LLC | 2022-02-18 |
| 10192253012859 | CARDINAL HEALTH | Cardinal Health 200, LLC | 2022-02-18 |