| Device Type ID | 1709 |
| Device Name | Dilator, Catheter, Ureteral |
| Regulation Description | Ureteral Dilator. |
| 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) |
| CFR Regulation Number | 876.5470 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | EZN |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Expansion Pilot Program |
| Device Type ID | 1709 |
| Device | Dilator, Catheter, Ureteral |
| Product Code | EZN |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Ureteral Dilator. |
| CFR Regulation Number | 876.5470 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
COLOPLAST CORP | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
COLOPLAST MANUFACTURING US LLC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
COOK, INC. | ||
SUBSTANTIALLY EQUIVALENT - KIT | 1 | |
SUBSTANTIALLY EQUIVALENT | 3 | |
| Device Problems | |
|---|---|
Burst Container Or Vessel | 23 |
Catheter | 20 |
Kinked | 18 |
Balloon | 13 |
Deflation Problem | 8 |
Material Rupture | 7 |
Device Packaging Compromised | 6 |
Seal | 6 |
Difficult To Remove | 4 |
Inflation Problem | 3 |
Bent | 3 |
Tip | 3 |
Shaft | 3 |
Adverse Event Without Identified Device Or Use Problem | 3 |
Leak / Splash | 3 |
Device Contamination With Chemical Or Other Material | 3 |
Break | 3 |
Material Deformation | 2 |
Material Separation | 2 |
Misassembled | 2 |
Balloon Rupture | 2 |
Material Puncture / Hole | 2 |
Device Operates Differently Than Expected | 2 |
Tear, Rip Or Hole In Device Packaging | 2 |
Material Integrity Problem | 1 |
Use Of Device Problem | 1 |
Deformation Due To Compressive Stress | 1 |
Balloon Burst | 1 |
Appropriate Term/Code Not Available | 1 |
Hole In Material | 1 |
Physical Resistance / Sticking | 1 |
Difficult To Position | 1 |
Torn Material | 1 |
| Total Device Problems | 152 |