FDA product code QTH: Endoscopic Light-Projecting Measuring Device
QTH is the FDA product code for endoscopic light-projecting measuring device. It is a Class II device, regulated under 21 CFR 876.1530 and reviewed by the Gastroenterology and Urology panel. Devices under QTH reach the market by 510(k); FDA lists no cleared 510(k)s for it. 1 De Novo request was granted under it.
Definition
An endoscopic light-projecting measuring device projects light on a mucosal surface and uses software to determine the dimensions of observable features of interest.
Classification
| Field | Value |
|---|---|
| Device name | Endoscopic Light-Projecting Measuring Device |
| Device class | Class II |
| Regulation | 21 CFR 876.1530 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) |
Recalls for QTH devices
openFDA lists no recalls for product code QTH.
Frequently asked questions
What is FDA product code QTH?
QTH is the FDA product code for endoscopic light-projecting measuring device. It is a Class II device, regulated under 21 CFR 876.1530 and reviewed by the Gastroenterology and Urology panel.
What device class is QTH?
Class II, regulation 21 CFR 876.1530. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code QTH
- Run a recall and safety report across every QTH manufacturer
- Watch product code QTH 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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