FDA product code FCZ: Tube, Smoke Removal, Endoscopic
FCZ is the FDA product code for tube, smoke removal, endoscopic. It is a Class I device, regulated under 21 CFR 876.1500 and reviewed by the Gastroenterology and Urology panel. Devices under FCZ reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Tube, Smoke Removal, Endoscopic |
| Device class | Class I |
| Regulation | 21 CFR 876.1500 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) exempt |
Recalls for FCZ devices
openFDA lists no recalls for product code FCZ.
Frequently asked questions
What is FDA product code FCZ?
FCZ is the FDA product code for tube, smoke removal, endoscopic. It is a Class I device, regulated under 21 CFR 876.1500 and reviewed by the Gastroenterology and Urology panel.
What device class is FCZ?
Class I, regulation 21 CFR 876.1500. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code FCZ
- Run a recall and safety report across every FCZ manufacturer
- Watch product code FCZ 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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