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