FDA product code SCT: Foley Catheters And Accessories With Additional Safety Features
SCT is the FDA product code for foley catheters and accessories with additional safety features. It is a Class II device, regulated under 21 CFR 876.5130 and reviewed by the Gastroenterology and Urology panel. Devices under SCT reach the market by 510(k); FDA lists no cleared 510(k)s for it.
Definition
Foley catheters intended for urine drainage with additional safety features to reduce potential injury to the urethra and/or bladder. These catheters do not include design features intended to reduce infections.
Classification
| Field | Value |
|---|---|
| Device name | Foley Catheters And Accessories With Additional Safety Features |
| Device class | Class II |
| Regulation | 21 CFR 876.5130 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) |
Recalls for SCT devices
openFDA lists no recalls for product code SCT.
Frequently asked questions
What is FDA product code SCT?
SCT is the FDA product code for foley catheters and accessories with additional safety features. It is a Class II device, regulated under 21 CFR 876.5130 and reviewed by the Gastroenterology and Urology panel.
What device class is SCT?
Class II, regulation 21 CFR 876.5130. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code SCT
- Run a recall and safety report across every SCT manufacturer
- Watch product code SCT 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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