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 |