FDA product code PJH
Dynamic Rectal Control System
Gastroenterology, Urology·Class 2·21 CFR 876.5930
US regulatory classifications
- US Product Code (FDA)
- PJHView Product Code Classification →
- US Risk Class (FDA)
- Class 2
- US Regulation (CFR)
- 21 CFR 876.5930View CFR Regulation →
- Medical specialty
- Gastroenterology, Urology
Device characteristics
- GMP exempt
- No
- Implantable
- No
- Life-sustaining
- No
- Third party review
- Not Eligible
Definition
Intended to treat fecal incontinence by controlling the size of the rectal lumen.
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About this record
Dynamic Rectal Control System is a medical device type in the Gastroenterology, Urology specialty. This page includes real-world medical device registration data worldwide for this device type, with registrations from US FDA, Brazil ANVISA, and other global markets.
View regulatory classifications, recent 510(k) clearances, active device registrations, and similar products registered globally under this device category. Pure Global AI's free directory provides comprehensive worldwide registration intelligence across 7,000+ medical device types and 21 specialties.