| Device Type ID | 1927 |
| Device Name | Catheter, Urethral |
| 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 | GBM |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Program |
|
| Device Type ID | 1927 |
| Device | Catheter, Urethral |
| Product Code | GBM |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Urological Catheter And Accessories. |
| CFR Regulation Number | 876.5130 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
B. BRAUN MEDICAL INC. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
B. BRAUN MEDICAL, INC. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
COLOPLAST CORP. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
COLOPLAST MANUFACTURING US LLC | ||
SUBSTANTIALLY EQUIVALENT | 4 | |
CONVATEC INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
CONVATEC LIMITED | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
COOK, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
HOLLISTER INCORPORATED | ||
SUBSTANTIALLY EQUIVALENT | 5 | |
HOLLISTER, INC. | ||
SUBSTANTIALLY EQUIVALENT | 6 | |
ROBLING MEDICAL | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Adverse Event Without Identified Device Or Use Problem | 19 |
Break | 13 |
Catheter | 12 |
Difficult To Remove | 7 |
Material Invagination | 5 |
Burst Container Or Vessel | 4 |
Partial Blockage | 3 |
Mushroomed | 2 |
Leak / Splash | 2 |
Packaging Problem | 2 |
Device Damaged Prior To Use | 2 |
Product Quality Problem | 2 |
Delivered As Unsterile Product | 2 |
Balloon | 1 |
Shaft | 1 |
Deflation Problem | 1 |
Tear, Rip Or Hole In Device Packaging | 1 |
Ambient Temperature Problem | 1 |
Patient-Device Incompatibility | 1 |
Sharp Edges | 1 |
Restricted Flow Rate | 1 |
Difficult To Insert | 1 |
Torn Material | 1 |
Material Too Soft / Flexible | 1 |
Device Or Device Fragments Location Unknown | 1 |
Failure To Infuse | 1 |
Device Contaminated During Manufacture Or Shipping | 1 |
Material Deformation | 1 |
Detachment Of Device Component | 1 |
Material Fragmentation | 1 |
| Total Device Problems | 92 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Teleflex Medical Europe Ltd | II | Apr-12-2018 |