Definition: For Use In The Ureter To Prevent The Migration Of Urinary Calculi And Their Fragments During Intracorporeal Lithotripsy Procedures.
| Device Type ID | 2079 |
| Device Name | Dissolvable Gel For Preventing Ureteral Stone Migration |
| Physical State | The Device Is An Injectable Gel That Is Capable Of Being Dissolved Using Endoscopic Irrigation. |
| Technical Method | The Gel Temporarily Obstructs The Ureter To Limit The Migration Of Urinary Calculi And Their Fragments During Intracorporeal Lithotripsy Procedures. After The Lithotripsy Procedure, The Gel Is Dissolved Using Irrigation. |
| Target Area | The Target Area Is The Ureter. |
| 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 | ONJ |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 2079 |
| Device | Dissolvable Gel For Preventing Ureteral Stone Migration |
| Product Code | ONJ |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Ureteral Stone Dislodger. |
| CFR Regulation Number | 876.4680 [🔎] |