NZC · Class III — High Risk (PMA approval required, life-sustaining) · Unknown
Classification
FDA Product Code
NZC
Device class
Class III — High Risk (PMA approval required, life-sustaining)
Regulation
—
Review panel
GU
Medical specialty
Unknown
Submission type
2
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
N
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.