Product code NZU— Gastroenterology, Urology
URASSIST
- Classification name
- Collector, Urine, Powered, Non Indwelling Catheter
- Device class
- Class 1
- Regulation
- 21 CFR 876.5250
- Advisory panel
- Gastroenterology, Urology
- Total cleared
- 1
- First cleared
- Most recent
FDA classification definition
“For the non-invasive, non-sterile collection of urine and for patients unable to void on their own or have control of voiding. Often patient confined to the bed or a wheelchair.”
Market context for product code NZU
FDA has cleared device under product code NZU, all in 2006, filed by 1 applicant company. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.
Top applicants under product code NZU
Adverse events under product code NZU
product code NZU- Death
- 11
- Injury
- 1,672
- Malfunction
- 1,452
- Other
- 1
- Total
- 3,136
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recent clearances under product code NZU
Data sourced from openFDA. This site is unofficial and independent of the FDA.