Dynamic Rectal Control System
The Dynamic Rectal Control System is a medical device intended to treat fecal incontinence by dynamically controlling the size of the rectal lumen, providing a mechanically adjustable solution for patients who cannot achieve continence through other means. It is an FDA Class 2 device regulated under 21 CFR 876.5930, requiring 510(k) premarket notification, within the Gastroenterology and Urology (GU) medical specialty. The product code is PJH. This device is not implantable and is not life-sustaining.
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Basic Information
- Product Code
- PJH
- Device Class
- FDA class 2
- Regulation Number
- 876.5930
- Medical Specialty
- Gastroenterology, Urology
- Review Panel
- GU
- Submission Type
- 1
Device Characteristics
Definition
Intended to treat fecal incontinence by controlling the size of the rectal lumen.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 2 510(k) clearances via K numbers.
FEI Numbers
This FDA classification entry is associated with 1 FEI number. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 1 registration number. Click on an entry to view related FDA registrations.