| Device Type ID | 1829 |
| Device Name | Dislodger, Stone, Flexible |
| Regulation Description | Ureteral Stone Dislodger. |
| 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 | 876.4680 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | FGO |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
|
| Device Type ID | 1829 |
| Device | Dislodger, Stone, Flexible |
| Product Code | FGO |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Ureteral Stone Dislodger. |
| CFR Regulation Number | 876.4680 [🔎] |
| Device Problems | |
|---|---|
Coil | 19 |
Peeled / Delaminated | 18 |
Detachment Of Device Or Device Component | 18 |
Break | 7 |
Detachment Of Device Component | 7 |
Material Frayed | 5 |
Tip | 3 |
Difficult To Open Or Close | 2 |
Wire | 2 |
Difficult To Remove | 2 |
Material Deformation | 2 |
Material Separation | 2 |
Entrapment Of Device | 2 |
Torn Material | 1 |
Migration Or Expulsion Of Device | 1 |
Tear, Rip Or Hole In Device Packaging | 1 |
Delivered As Unsterile Product | 1 |
Adverse Event Without Identified Device Or Use Problem | 1 |
Deformation Due To Compressive Stress | 1 |
| Total Device Problems | 95 |