FDA product code QWU: Prosthesis, Eyelid Spacer/Graft, Polymer
QWU is the FDA product code for prosthesis, eyelid spacer/graft, polymer. It is a Class II device, regulated under 21 CFR 886.3130 and reviewed by the Ophthalmic panel. FDA has cleared 1 510(k) submission under QWU, 1 in the last five years. The average 510(k) review took 245 days (median 245). FDA has posted 3 recalls for QWU devices, 3 initiated in the last five years.
Definition
For implantation to reinforce and aid in reconstruction of the soft tissues of the eyelid and eyelid area.
Classification
| Field | Value |
|---|---|
| Device name | Prosthesis, Eyelid Spacer/Graft, Polymer |
| Device class | Class II |
| Regulation | 21 CFR 886.3130 |
| Review panel | OP — Ophthalmic |
| Medical specialty | Ophthalmic |
| Premarket route | 510(k) exempt |
| Implant | Yes |
510(k) clearances per year for QWU
| Year | Clearances | Avg. review days |
|---|---|---|
| 2023 | 1 | 245 |
Compare with all 510(k) review times · Search every QWU clearance
Top QWU applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Corneat Vision , Ltd. | 1 | 2023-06-02 |
Most recent QWU clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K223074 | Corneat Vision , Ltd. | CorNeat EverPatch | 2023-06-02 | 245 |
Recalls for QWU devices
3 product recalls in 2 recall events; 3 initiated in the last five years and 3 still open. Most recent: 2025-08-18.
| Year | Recalls |
|---|---|
| 2024 | 1 |
| 2025 | 2 |
Frequently asked questions
What is FDA product code QWU?
QWU is the FDA product code for prosthesis, eyelid spacer/graft, polymer. It is a Class II device, regulated under 21 CFR 886.3130 and reviewed by the Ophthalmic panel.
What device class is QWU?
Class II, regulation 21 CFR 886.3130. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code QWU?
Across 1 cleared submissions the average was 245 days from receipt to decision (median 245).
Which companies have the most QWU clearances?
Corneat Vision , Ltd. (1).
Have QWU devices been recalled?
Yes: 3 product recalls across 2 recall events; the most recent began 2025-08-18.
Next steps
- Run an FDA pathway report with predicate devices for product code QWU
- Run a recall and safety report across every QWU manufacturer
- Watch product code QWU 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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