FDA product code HRB: Microscope, Operating, Non-Electric, Ophthalmic
HRB is the FDA product code for microscope, operating, non-electric, ophthalmic. It is a Class I device, regulated under 21 CFR 878.4700 and reviewed by the General and Plastic Surgery panel. Devices under HRB reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Microscope, Operating, Non-Electric, Ophthalmic |
| Device class | Class I |
| Regulation | 21 CFR 878.4700 |
| Review panel | SU — General and Plastic Surgery |
| Medical specialty | General, Plastic Surgery |
| Premarket route | 510(k) exempt |
Recalls for HRB devices
openFDA lists no recalls for product code HRB.
Frequently asked questions
What is FDA product code HRB?
HRB is the FDA product code for microscope, operating, non-electric, ophthalmic. It is a Class I device, regulated under 21 CFR 878.4700 and reviewed by the General and Plastic Surgery panel.
What device class is HRB?
Class I, regulation 21 CFR 878.4700. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code HRB
- Run a recall and safety report across every HRB manufacturer
- Watch product code HRB 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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