| Device Type ID | 1692 |
| Device Name | Catheter, Ureteral, Gastro-urology |
| Regulation Description | 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 | 876.5130 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | EYB |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Program |
|
| Device Type ID | 1692 |
| Device | Catheter, Ureteral, Gastro-urology |
| Product Code | EYB |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Urological Catheter And Accessories. |
| CFR Regulation Number | 876.5130 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
BOSTON SCIENTIFIC CORP. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
BOSTON SCIENTIFIC CORPORATION | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
COLOPLAST CORP | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
COLOPLAST MANUFACTURING US LLC | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
COOK, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Break | 6 |
Inflation Problem | 3 |
Deflation Problem | 2 |
Device Damaged Prior To Use | 2 |
Material Fragmentation | 1 |
Material Separation | 1 |
Device Damaged By Another Device | 1 |
Incorrect Measurement | 1 |
Material Puncture / Hole | 1 |
Catheter | 1 |
Tip | 1 |
Difficult To Remove | 1 |
Burst Container Or Vessel | 1 |
| Total Device Problems | 22 |