Product code SCT
- Device name
- Foley Catheters And Accessories With Additional Safety Features
- Medical specialty
- Gastroenterology, Urology
- Device class
- 2
- Regulation number
- 876.5130
- Review panel
- GU
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Ineligible
- Definition
- Foley catheters intended for urine drainage with additional safety features to reduce potential injury to the urethra and/or bladder. These catheters do not include design features intended to reduce infections.
- Source
- FDA openFDA device classification dataset