| Device Type ID | 1697 |
| Device Name | Holder, Ureteral Catheter |
| 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 | EYJ |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
|
| Device Type ID | 1697 |
| Device | Holder, Ureteral Catheter |
| Product Code | EYJ |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Urological Catheter And Accessories. |
| CFR Regulation Number | 876.5130 [🔎] |
| Device Problems | |
|---|---|
Disconnection | 61 |
Fitting Problem | 20 |
Loss Of Or Failure To Bond | 14 |
Patient-Device Incompatibility | 7 |
Failure To Adhere Or Bond | 6 |
Use Of Device Problem | 3 |
Break | 2 |
Nonstandard Device | 2 |
Physical Resistance / Sticking | 1 |
Material Separation | 1 |
Misassembled | 1 |
Device Operates Differently Than Expected | 1 |
Material Twisted / Bent | 1 |
Migration Or Expulsion Of Device | 1 |
| Total Device Problems | 121 |