Product code PIH
- Device name
- Urethral Insert With Pump For Bladder Drainage
- Medical specialty
- Gastroenterology, Urology
- Device class
- 2
- Regulation number
- 876.5140
- Review panel
- GU
- Implant
- Y
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Definition
- The device is intended to empty urine from the bladder under patient control.
- Source
- FDA openFDA device classification dataset