| Device Type ID | 1965 |
| Device Name | Catheter, Suprapubic (and Accessories) |
| 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 | KOB |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | Yes |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 1965 |
| Device | Catheter, Suprapubic (and Accessories) |
| Product Code | KOB |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Suprapubic Urological Catheter And Accessories. |
| CFR Regulation Number | 876.5090 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
COOK, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
SUBSTANTIALLY EQUIVALENT - KIT | 2 | |
MEDIPLUS LTD. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Break | 6 |
Leak / Splash | 2 |
Material Separation | 2 |
Deflation Problem | 2 |
Component Missing | 1 |
Device Dislodged Or Dislocated | 1 |
Catheter | 1 |
Occlusion Within Device | 1 |
Adverse Event Without Identified Device Or Use Problem | 1 |
Burst Container Or Vessel | 1 |
Inflation Problem | 1 |
Material Fragmentation | 1 |
Difficult To Position | 1 |
Detachment Of Device Or Device Component | 1 |
Torn Material | 1 |
Difficult To Advance | 1 |
| Total Device Problems | 24 |