510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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NZCClass III

Stent, Urethral, Prostatic, Semi-Permanent

Unknown
FDA source (opens on fda.gov)

NZC is the FDA product code for Stent, Urethral, Prostatic, Semi-Permanent, a class III device type. FDA's definition for this code reads: "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...". As of , FDA records hold no 510(k) clearances under this code and no recalls.

Classification record

Product code
NZC
Device name
Stent, Urethral, Prostatic, Semi-Permanent
FDA 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.
Device class
Class III
Review panel
Unknown
Submission type
PMA
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
0
Ingested recalls
0

Companies listing this code with FDA

Companies whose registered establishments list this code