FDA product code HDO: Valve, Tubal Occlusion
HDO is the FDA product code for valve, tubal occlusion. It is a Class III device, regulated under 21 CFR 884.5380 and reviewed by the Obstetrics and Gynecology panel. Devices under HDO reach the market by PMA; FDA lists no cleared 510(k)s for it.
Definition
Call for PMAs 12/30/87 (52 FR 36883 10/1/87))
Classification
| Field | Value |
|---|---|
| Device name | Valve, Tubal Occlusion |
| Device class | Class III |
| Regulation | 21 CFR 884.5380 |
| Review panel | OB — Obstetrics and Gynecology |
| Medical specialty | Obstetrics/Gynecology |
| Premarket route | PMA |
| Implant | Yes |
Recalls for HDO devices
openFDA lists no recalls for product code HDO.
Frequently asked questions
What is FDA product code HDO?
HDO is the FDA product code for valve, tubal occlusion. It is a Class III device, regulated under 21 CFR 884.5380 and reviewed by the Obstetrics and Gynecology panel.
What device class is HDO?
Class III, regulation 21 CFR 884.5380. Typical premarket route: PMA.
Next steps
- Run an FDA pathway report with predicate devices for product code HDO
- Run a recall and safety report across every HDO manufacturer
- Watch product code HDO 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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