| Device Type ID | 1743 |
| Device Name | Sound, Urethral, Metal Or Plastic |
| 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 1 Medical Device |
| Product Code | FBX |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 1743 |
| Device | Sound, Urethral, Metal Or Plastic |
| Product Code | FBX |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Urethral Dilator. |
| CFR Regulation Number | 876.5520 [🔎] |
| Device Problems | |
|---|---|
Device Unsafe To Use In Environment | 1 |
Defective Device | 1 |
Adverse Event Without Identified Device Or Use Problem | 1 |
| Total Device Problems | 3 |