FDA product code HBS: Instrument, Clip Forming/Cutting
HBS is the FDA product code for instrument, clip forming/cutting. It is a Class I device, regulated under 21 CFR 882.4190 and reviewed by the Neurology panel. Devices under HBS reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Instrument, Clip Forming/Cutting |
| Device class | Class I |
| Regulation | 21 CFR 882.4190 |
| Review panel | NE — Neurology |
| Medical specialty | Neurology |
| Premarket route | 510(k) exempt |
Recalls for HBS devices
openFDA lists no recalls for product code HBS.
Frequently asked questions
What is FDA product code HBS?
HBS is the FDA product code for instrument, clip forming/cutting. It is a Class I device, regulated under 21 CFR 882.4190 and reviewed by the Neurology panel.
What device class is HBS?
Class I, regulation 21 CFR 882.4190. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code HBS
- Run a recall and safety report across every HBS manufacturer
- Watch product code HBS 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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