PJH — Dynamic Rectal Control System Class II
FDA product code PJH covers "Dynamic Rectal Control System", a Class II medical device regulated under 21 CFR 876.5930. Submissions are reviewed by the Gastroenterology, Urology panel. At least 2 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- PJH
- Device Class
- Class II
- Regulation Number
- 876.5930
- Submission Type
- Review Panel
- GU
- Medical Specialty
- Gastroenterology, Urology
- Implant
- No
Definition
Intended to treat fecal incontinence by controlling the size of the rectal lumen.