| Device Type ID | 1968 |
| Device Name | Dilator, Urethral |
| Regulation Description | Urethral 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) Exempt |
| CFR Regulation Number | 876.5520 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | KOE |
| 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 | 1968 |
| Device | Dilator, Urethral |
| Product Code | KOE |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Urethral Dilator. |
| CFR Regulation Number | 876.5520 [🔎] |
| Device Problems | |
|---|---|
Peeled / Delaminated | 8 |
Device Contamination With Chemical Or Other Material | 7 |
Material Separation | 5 |
Flaked | 4 |
Device Contaminated During Manufacture Or Shipping | 2 |
Material Integrity Problem | 2 |
Adverse Event Without Identified Device Or Use Problem | 2 |
Use Of Device Problem | 2 |
Component Missing | 1 |
Physical Property Issue | 1 |
Catheter | 1 |
Appropriate Term/Code Not Available | 1 |
Balloon Rupture | 1 |
Material Frayed | 1 |
Material Discolored | 1 |
Product Quality Problem | 1 |
Defective Component | 1 |
Tear, Rip Or Hole In Device Packaging | 1 |
Burst Container Or Vessel | 1 |
Device Operates Differently Than Expected | 1 |
Device Operational Issue | 1 |
Material Deformation | 1 |
Leak / Splash | 1 |
Device Damaged By Another Device | 1 |
Unsealed Device Packaging | 1 |
Difficult To Insert | 1 |
Difficult To Advance | 1 |
Component Falling | 1 |
Break | 1 |
Component(s), Broken | 1 |
Other (for Use When An Appropriate Device Code Cannot Be Identified) | 1 |
Detachment Of Device Or Device Component | 1 |
| Total Device Problems | 56 |