| Device Type ID | 1784 |
| Device Name | Tube, Double Lumen For Intestinal Decompression And/or Intubation |
| Regulation Description | Gastrointestinal Tube And Accessories. |
| Regulation Medical Specialty | Gastroenterology/Urology |
| Review Panel | Gastroenterology/Urology |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Reproductive, Gastro-Renal, And Urological Devices (DRGUD) Gastroenterology Devices Branch (GEDB) |
| Submission Type | 510(k) |
| CFR Regulation Number | 876.5980 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | FEG |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Expansion Pilot Program |
|
| Device Type ID | 1784 |
| Device | Tube, Double Lumen For Intestinal Decompression And/or Intubation |
| Product Code | FEG |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Gastrointestinal Tube And Accessories. |
| CFR Regulation Number | 876.5980 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
COOK IRELAND LTD | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Break | 3 |
Hole In Material | 2 |
Migration Or Expulsion Of Device | 2 |
Suction Problem | 2 |
Catheter | 1 |
Appropriate Term/Code Not Available | 1 |
Incorrect Measurement | 1 |
Device Operates Differently Than Expected | 1 |
Fracture | 1 |
Off-Label Use | 1 |
Partial Blockage | 1 |
Detachment Of Device Or Device Component | 1 |
| Total Device Problems | 17 |