FDA product code HEZ: Endoscope, Transcervical (Amnioscope)(And Accessories)
HEZ is the FDA product code for endoscope, transcervical (amnioscope)(and accessories). It is a Class II device, regulated under 21 CFR 884.1660 and reviewed by the Obstetrics and Gynecology panel. Devices under HEZ reach the market by 510(k); FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Endoscope, Transcervical (Amnioscope)(And Accessories) |
| Device class | Class II |
| Regulation | 21 CFR 884.1660 |
| Review panel | OB — Obstetrics and Gynecology |
| Medical specialty | Obstetrics/Gynecology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Recalls for HEZ devices
openFDA lists no recalls for product code HEZ.
Frequently asked questions
What is FDA product code HEZ?
HEZ is the FDA product code for endoscope, transcervical (amnioscope)(and accessories). It is a Class II device, regulated under 21 CFR 884.1660 and reviewed by the Obstetrics and Gynecology panel.
What device class is HEZ?
Class II, regulation 21 CFR 884.1660. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code HEZ
- Run a recall and safety report across every HEZ manufacturer
- Watch product code HEZ 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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