FDA product code LCG: Intestinal Splinting Tubes
LCG is the FDA product code for intestinal splinting tubes. It is a Class II device, regulated under 21 CFR 876.5980 and reviewed by the Gastroenterology and Urology panel. Devices under LCG reach the market by 510(k); FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Intestinal Splinting Tubes |
| Device class | Class II |
| Regulation | 21 CFR 876.5980 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Recalls for LCG devices
openFDA lists no recalls for product code LCG.
Frequently asked questions
What is FDA product code LCG?
LCG is the FDA product code for intestinal splinting tubes. It is a Class II device, regulated under 21 CFR 876.5980 and reviewed by the Gastroenterology and Urology panel.
What device class is LCG?
Class II, regulation 21 CFR 876.5980. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code LCG
- Run a recall and safety report across every LCG manufacturer
- Watch product code LCG 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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