NZU — Collector, Urine, Powered, Non Indwelling Catheter Class I
FDA product code NZU covers "Collector, Urine, Powered, Non Indwelling Catheter", a Class I medical device regulated under 21 CFR 876.5250. Submissions are reviewed by the Gastroenterology, Urology panel. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- NZU
- Device Class
- Class I
- Regulation Number
- 876.5250
- Submission Type
- Review Panel
- GU
- Medical Specialty
- Gastroenterology, Urology
- Implant
- No
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K062061 | preferred medical devices | URASSIST | October 5, 2006 |