FDA product code HFY: Band, Tubal Occlusion
HFY is the FDA product code for band, tubal occlusion. It is a Class III device, regulated under 21 CFR 884.5380 and reviewed by the Obstetrics and Gynecology panel. Devices under HFY 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 | Band, 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 HFY devices
openFDA lists no recalls for product code HFY.
Frequently asked questions
What is FDA product code HFY?
HFY is the FDA product code for band, 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 HFY?
Class III, regulation 21 CFR 884.5380. Typical premarket route: PMA.
Next steps
- Run an FDA pathway report with predicate devices for product code HFY
- Run a recall and safety report across every HFY manufacturer
- Watch product code HFY 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.
All Obstetrics and Gynecology product codes · FDA product code lookup · 510(k) database search · 510(k) review times