FDA product code GCH: Mediastinoscope, Diagnostic
GCH is the FDA product code for mediastinoscope, diagnostic. It is a Class II device, regulated under 21 CFR 876.1500 and reviewed by the General and Plastic Surgery panel. Devices under GCH reach the market by 510(k); FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Mediastinoscope, Diagnostic |
| Device class | Class II |
| Regulation | 21 CFR 876.1500 |
| Review panel | SU — General and Plastic Surgery |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) |
Recalls for GCH devices
openFDA lists no recalls for product code GCH.
Frequently asked questions
What is FDA product code GCH?
GCH is the FDA product code for mediastinoscope, diagnostic. It is a Class II device, regulated under 21 CFR 876.1500 and reviewed by the General and Plastic Surgery panel.
What device class is GCH?
Class II, regulation 21 CFR 876.1500. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code GCH
- Run a recall and safety report across every GCH manufacturer
- Watch product code GCH 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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