Definition: Approximately 3 Cm Tube Placed In The Prostatic Urethra For Short Term Use To Drain Urine. The Device Includes A Retention Mechanism That Anchors In The Bladder Neck To Hold It In Place And A Release Mechanism That Exits The Penis. For Short Term Use
| Device Type ID | 2218 |
| Device Name | Stent, Urethral, Prostatic, Semi-permanent |
| Physical State | Approximately 3 Centimeter Tube (i.e. Length Of Prostatic Urethra) That Is Inserted Into The Prostatic Urethra And Includes A Proximal Retention Component That Anchors The Device In The Bladder Neck And A Suture-type Material On The Distal End That E |
| Technical Method | The Urethral Stent Crosses A Partially Or Fully Obstructed Prostatic Urethra To Allow Passage Of Urine. |
| Target Area | Prostatic Urethra. |
| 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 | PMA |
| FDA Device Classification | Class 3 Medical Device |
| Product Code | NZC |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 2218 |
| Device | Stent, Urethral, Prostatic, Semi-permanent |
| Product Code | NZC |
| FDA Device Classification | Class 3 Medical Device |