FDA product code QUQ: Knife, Intraocular Pressure Lowering
QUQ is the FDA product code for knife, intraocular pressure lowering. It is a Class II device, regulated under 21 CFR 878.4400 and reviewed by the Ophthalmic panel. FDA has cleared 1 510(k) submission under QUQ, 1 in the last five years. The average 510(k) review took 781 days (median 781); 781 days on average over the last three years.
Definition
A knife intended for cutting of trabecular meshwork to reduce intraocular pressure in glaucoma
Classification
| Field | Value |
|---|---|
| Device name | Knife, Intraocular Pressure Lowering |
| Device class | Class II |
| Regulation | 21 CFR 878.4400 |
| Review panel | OP — Ophthalmic |
| Medical specialty | General, Plastic Surgery |
| Premarket route | 510(k) |
510(k) clearances per year for QUQ
| Year | Clearances | Avg. review days |
|---|---|---|
| 2024 | 1 | 781 |
Compare with all 510(k) review times · Search every QUQ clearance
Top QUQ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| New World Medical, Inc. | 1 | 2024-05-17 |
Most recent QUQ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K220891 | New World Medical, Inc. | Kahook Dual Blade Glide (KDB Glide) | 2024-05-17 | 781 |
Recalls for QUQ devices
openFDA lists no recalls for product code QUQ.
Frequently asked questions
What is FDA product code QUQ?
QUQ is the FDA product code for knife, intraocular pressure lowering. It is a Class II device, regulated under 21 CFR 878.4400 and reviewed by the Ophthalmic panel.
What device class is QUQ?
Class II, regulation 21 CFR 878.4400. Typical premarket route: 510(k).
How long does a 510(k) take for product code QUQ?
Across 1 cleared submissions the average was 781 days from receipt to decision (median 781).
Which companies have the most QUQ clearances?
New World Medical, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code QUQ
- Run a recall and safety report across every QUQ manufacturer
- Watch product code QUQ 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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