FDA product code FHI: Ring, Laparotomy
FHI is the FDA product code for ring, laparotomy. It is a Class I device, regulated under 21 CFR 876.4730 and reviewed by the Gastroenterology and Urology panel. Devices under FHI reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it. FDA has posted 10 recalls for FHI devices.
Classification
| Field | Value |
|---|---|
| Device name | Ring, Laparotomy |
| Device class | Class I |
| Regulation | 21 CFR 876.4730 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) exempt |
Recalls for FHI devices
10 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2014-05-20.
Frequently asked questions
What is FDA product code FHI?
FHI is the FDA product code for ring, laparotomy. It is a Class I device, regulated under 21 CFR 876.4730 and reviewed by the Gastroenterology and Urology panel.
What device class is FHI?
Class I, regulation 21 CFR 876.4730. Typical premarket route: 510(k) exempt.
Have FHI devices been recalled?
Yes: 10 product recalls across 1 recall events; the most recent began 2014-05-20.
Next steps
- Run an FDA pathway report with predicate devices for product code FHI
- Run a recall and safety report across every FHI manufacturer
- Watch product code FHI 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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