NZU
1 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Collector, Urine, Powered, Non Indwelling Catheter
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 876.5250
- Medical specialty
- Gastroenterology, Urology
- Flags
- GMP exempt
- FDA 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.
- Adverse events (MAUDE)
- 2021: 605 · 2022: 516 · 2023: 241 · 2024: 143 · 2025: 1,133 · 2026: 993
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| URASSIST (K062061) | Preferred Medical Devices, Inc. | 2006-10-05 |
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Every clearance here is in the API, with alerts when new ones post.