FDA product code QHC: Instrument, Biopsy, Core, Soft Tissue, Female Reproductive Organs
QHC is the FDA product code for instrument, biopsy, core, soft tissue, female reproductive organs. It is a Class II device, regulated under 21 CFR 876.1075 and reviewed by the Obstetrics and Gynecology panel. Devices under QHC reach the market by 510(k); FDA lists no cleared 510(k)s for it.
Definition
Obtain core soft tissue biopsy samples of internal female reproductive organs such as uterus, ovaries, and retroperitoneal lymph nodes.
Classification
| Field | Value |
|---|---|
| Device name | Instrument, Biopsy, Core, Soft Tissue, Female Reproductive Organs |
| Device class | Class II |
| Regulation | 21 CFR 876.1075 |
| Review panel | OB — Obstetrics and Gynecology |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) |
Recalls for QHC devices
openFDA lists no recalls for product code QHC.
Frequently asked questions
What is FDA product code QHC?
QHC is the FDA product code for instrument, biopsy, core, soft tissue, female reproductive organs. It is a Class II device, regulated under 21 CFR 876.1075 and reviewed by the Obstetrics and Gynecology panel.
What device class is QHC?
Class II, regulation 21 CFR 876.1075. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code QHC
- Run a recall and safety report across every QHC manufacturer
- Watch product code QHC 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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