| Device Type ID | 1691 |
| Device Name | Stylet, Ureteral |
| 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) Exempt |
| CFR Regulation Number | 876.5130 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | EYA |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
|
| Device Type ID | 1691 |
| Device | Stylet, Ureteral |
| Product Code | EYA |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Urological Catheter And Accessories. |
| CFR Regulation Number | 876.5130 [🔎] |
| Device Problems | |
|---|---|
Unraveled Material | 10 |
Guidewire | 7 |
Break | 2 |
Flaked | 1 |
Detachment Of Device Component | 1 |
Peeled / Delaminated | 1 |
Material Fragmentation | 1 |
Uncoiled | 1 |
Adverse Event Without Identified Device Or Use Problem | 1 |
| Total Device Problems | 25 |