| Device Type ID | 1798 |
| Device Name | Tube, Drainage, Suprapubic |
| Regulation Description | Suprapubic Urological Catheter 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) Urology And Lithotripsy Devices Branch (ULDB) |
| Submission Type | 510(k) |
| CFR Regulation Number | 876.5090 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | FFA |
| 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 | 1798 |
| Device | Tube, Drainage, Suprapubic |
| Product Code | FFA |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Suprapubic Urological Catheter And Accessories. |
| CFR Regulation Number | 876.5090 [🔎] |
| Device Problems | |
|---|---|
Break | 55 |
Suture | 43 |
Catheter | 32 |
Hub | 13 |
Detachment Of Device Component | 11 |
Difficult To Remove | 9 |
Stent | 8 |
Device Packaging Compromised | 8 |
Entrapment Of Device | 7 |
Device Damaged Prior To Use | 7 |
Occlusion Within Device | 7 |
Migration Or Expulsion Of Device | 7 |
Fracture | 6 |
Adverse Event Without Identified Device Or Use Problem | 6 |
Cannula | 5 |
Detachment Of Device Or Device Component | 5 |
Device Contamination With Chemical Or Other Material | 4 |
Tear, Rip Or Hole In Device Packaging | 4 |
Device Operates Differently Than Expected | 3 |
Seal | 3 |
Device Dislodged Or Dislocated | 2 |
Shaft | 2 |
Calcified | 2 |
Guidewire | 2 |
Leak / Splash | 2 |
Peeled / Delaminated | 1 |
Air Leak | 1 |
Unsealed Device Packaging | 1 |
Material Separation | 1 |
Packaging Problem | 1 |
Crack | 1 |
Fluid Leak | 1 |
Shelf Life Exceeded | 1 |
Defective Device | 1 |
Device Or Device Fragments Location Unknown | 1 |
Kinked | 1 |
Material Discolored | 1 |
Wire | 1 |
Tip | 1 |
| Total Device Problems | 267 |