FDA product code QGJ: Corneal Inlay Inserter Handle
QGJ is the FDA product code for corneal inlay inserter handle. It is a Class I device, regulated under 21 CFR 886.4355 and reviewed by the Ophthalmic panel. Devices under QGJ reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Definition
The corneal inlay inserter handle is a hand-held device intended to be used as an accessory to a corneal inlay inserter. The device extends the length of the inlay inserter to aid in delivering the inlay implant.
Classification
| Field | Value |
|---|---|
| Device name | Corneal Inlay Inserter Handle |
| Device class | Class I |
| Regulation | 21 CFR 886.4355 |
| Review panel | OP — Ophthalmic |
| Medical specialty | Ophthalmic |
| Premarket route | 510(k) exempt |
Recalls for QGJ devices
openFDA lists no recalls for product code QGJ.
Frequently asked questions
What is FDA product code QGJ?
QGJ is the FDA product code for corneal inlay inserter handle. It is a Class I device, regulated under 21 CFR 886.4355 and reviewed by the Ophthalmic panel.
What device class is QGJ?
Class I, regulation 21 CFR 886.4355. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code QGJ
- Run a recall and safety report across every QGJ manufacturer
- Watch product code QGJ 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 Ophthalmic product codes · FDA product code lookup · 510(k) database search · 510(k) review times