510(k) K062061
K062061 is an FDA 510(k) premarket notification submitted by Preferred Medical Devices, Inc. for the device "URASSIST". The FDA issued a decision of Substantially Equivalent on October 5, 2006. The device falls under product code NZU (Collector, Urine, Powered, Non Indwelling Catheter), a Class I device regulated under 21 CFR 876.5250.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 5, 2006
- Date Received
- July 20, 2006
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Collector, Urine, Powered, Non Indwelling Catheter
- Device Class
- Class I
- Regulation Number
- 876.5250
- Review Panel
- GU
- Submission Type
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.