| Device Type ID | 1926 |
| Device Name | Catheter, Ureteral, General & Plastic Surgery |
| 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 | GBL |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Program |
|
| Device Type ID | 1926 |
| Device | Catheter, Ureteral, General & Plastic Surgery |
| Product Code | GBL |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Urological Catheter And Accessories. |
| CFR Regulation Number | 876.5130 [🔎] |
| Device Problems | |
|---|---|
Material Separation | 23 |
Break | 15 |
Device Contamination With Chemical Or Other Material | 6 |
Migration Or Expulsion Of Device | 4 |
Material Fragmentation | 3 |
Insufficient Information | 3 |
Flaked | 2 |
Device Damaged Prior To Use | 2 |
Peeled / Delaminated | 2 |
Tip Breakage | 2 |
Contamination / Decontamination Problem | 2 |
Catheter | 2 |
Appropriate Term/Code Not Available | 1 |
Stent | 1 |
Particulates | 1 |
Adverse Event Without Identified Device Or Use Problem | 1 |
Difficult To Remove | 1 |
Device Operates Differently Than Expected | 1 |
Partial Blockage | 1 |
Detachment Of Device Component | 1 |
Kinked | 1 |
Mechanical Problem | 1 |
| Total Device Problems | 76 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Cook Inc. | II | Aug-22-2016 |