SCT — Foley Catheters And Accessories With Additional Safety Features Class II
FDA product code SCT covers "Foley Catheters And Accessories With Additional Safety Features", a Class II medical device regulated under 21 CFR 876.5130. Submissions are reviewed by the Gastroenterology, Urology panel.
Classification Details
- Product Code
- SCT
- Device Class
- Class II
- Regulation Number
- 876.5130
- Submission Type
- Review Panel
- GU
- Medical Specialty
- Gastroenterology, Urology
- Implant
- No
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.