NZC — Stent, Urethral, Prostatic, Semi-Permanent Class III
FDA product code NZC covers "Stent, Urethral, Prostatic, Semi-Permanent", a Class III medical device. Submissions are reviewed by the Unknown panel.
Classification Details
- Product Code
- NZC
- Device Class
- Class III
- Regulation Number
- Submission Type
- Review Panel
- GU
- Medical Specialty
- Unknown
- Implant
- No
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 in men with partial of full prostatic urethral obstruction or the prevention of prostatic urethral obstruction post surgery or other prostatic treatment.