SJB — Powered Fecal Management System Class II
FDA product code SJB covers "Powered Fecal Management System", a Class II medical device regulated under 21 CFR 876.5230. Submissions are reviewed by the Gastroenterology, Urology panel. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- SJB
- Device Class
- Class II
- Regulation Number
- 876.5230
- Submission Type
- Review Panel
- GU
- Medical Specialty
- Gastroenterology, Urology
- Implant
- No
Definition
A powered fecal management system is a device that uses powered components to partially or fully divert and contain fecal waste away from a bed-ridden patient. This classification includes accessories such as filters, conduits for fecal waste transfer, and receptacles for fecal waste containment.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| DEN250043 | Cm Technologies | Qoramatic Automated Stool Management | Aug 20, 2026 |