| Device Type ID | 1920 |
| Device Name | Tube, Feeding |
| 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 | FPD |
| 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 | 1920 |
| Device | Tube, Feeding |
| Product Code | FPD |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Gastrointestinal Tube And Accessories. |
| CFR Regulation Number | 876.5980 [🔎] |
| Device Problems | |
|---|---|
Break | 11 |
Difficult To Remove | 9 |
Kinked | 8 |
Tube | 8 |
Material Too Rigid Or Stiff | 6 |
Insufficient Information | 6 |
Hole In Material | 5 |
Occlusion Within Device | 5 |
Obstruction Of Flow | 4 |
Incorrect Device Or Component Shipped | 4 |
Defective Device | 4 |
Cut In Material | 3 |
Device Markings / Labelling Problem | 3 |
Material Separation | 3 |
Connection Problem | 3 |
Delivered As Unsterile Product | 2 |
Tip | 2 |
Appropriate Term/Code Not Available | 2 |
Use Of Device Problem | 2 |
Device Operates Differently Than Expected | 2 |
Material Twisted / Bent | 2 |
Material Fragmentation | 2 |
Detachment Of Device Component | 2 |
Leak / Splash | 2 |
Positioning Problem | 2 |
Volume Accuracy Problem | 2 |
Malposition Of Device | 2 |
Detachment Of Device Or Device Component | 2 |
Fluid Leak | 2 |
Nonstandard Device | 1 |
Difficult To Position | 1 |
Probe | 1 |
Scratched Material | 1 |
Device Contamination With Chemical Or Other Material | 1 |
Knotted | 1 |
Partial Blockage | 1 |
Pump | 1 |
Device Packaging Compromised | 1 |
Infusion Or Flow Problem | 1 |
Cap | 1 |
Burst Container Or Vessel | 1 |
Fracture | 1 |
Migration Or Expulsion Of Device | 1 |
Defective Component | 1 |
Device Dislodged Or Dislocated | 1 |
Material Puncture / Hole | 1 |
Retraction Problem | 1 |
Misassembled | 1 |
| Total Device Problems | 129 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Benlan, Inc. | II | Jan-06-2016 |
| 2 | C.R. Bard, Inc. | II | Apr-11-2018 |
| 3 | Canadian Hospital Specialties | II | Jan-11-2019 |
| 4 | Canadian Hospital Specialties | II | Jul-13-2018 |
| 5 | ConvaTec, Inc | II | Mar-21-2019 |
| 6 | DeRoyal Industries Inc | II | Jan-16-2019 |
| 7 | Kentec Medical Inc | II | Jul-22-2017 |
| 8 | Neomed Inc | II | Oct-10-2018 |