FDA product code HKG: Fornixscope
HKG is the FDA product code for fornixscope. It is a Class I device, regulated under 21 CFR 886.1320 and reviewed by the Ophthalmic panel. Devices under HKG reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Fornixscope |
| Device class | Class I |
| Regulation | 21 CFR 886.1320 |
| Review panel | OP — Ophthalmic |
| Medical specialty | Ophthalmic |
| Premarket route | 510(k) exempt |
| GMP exempt | Yes |
Recalls for HKG devices
openFDA lists no recalls for product code HKG.
Frequently asked questions
What is FDA product code HKG?
HKG is the FDA product code for fornixscope. It is a Class I device, regulated under 21 CFR 886.1320 and reviewed by the Ophthalmic panel.
What device class is HKG?
Class I, regulation 21 CFR 886.1320. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code HKG
- Run a recall and safety report across every HKG manufacturer
- Watch product code HKG 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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