FDA product code SJB: Powered Fecal Management System
SJB is the FDA product code for powered fecal management system. It is a Class II device, regulated under 21 CFR 876.5230 and reviewed by the Gastroenterology and Urology panel. Devices under SJB reach the market by 510(k); FDA lists no cleared 510(k)s for it. 1 De Novo request was granted under it.
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.
Classification
| Field | Value |
|---|---|
| Device name | Powered Fecal Management System |
| Device class | Class II |
| Regulation | 21 CFR 876.5230 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) |
Recalls for SJB devices
openFDA lists no recalls for product code SJB.
Frequently asked questions
What is FDA product code SJB?
SJB is the FDA product code for powered fecal management system. It is a Class II device, regulated under 21 CFR 876.5230 and reviewed by the Gastroenterology and Urology panel.
What device class is SJB?
Class II, regulation 21 CFR 876.5230. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code SJB
- Run a recall and safety report across every SJB manufacturer
- Watch product code SJB for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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