FDA product code FXQ: Lens, Camera, Surgical
FXQ is the FDA product code for lens, camera, surgical. It is a Class I device, regulated under 21 CFR 878.4160 and reviewed by the General and Plastic Surgery panel. FDA has cleared 1 510(k) submission under FXQ. The average 510(k) review took 30 days (median 30).
Classification
| Field | Value |
|---|---|
| Device name | Lens, Camera, Surgical |
| Device class | Class I |
| Regulation | 21 CFR 878.4160 |
| Review panel | SU — General and Plastic Surgery |
| Medical specialty | General, Plastic Surgery |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every FXQ clearance
Top FXQ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Kelleher Corp. | 1 | 1982-07-09 |
Most recent FXQ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K821705 | Kelleher Corp. | NAGASHIMA F60MM ATTACH. LENS | 1982-07-09 | 30 |
Recalls for FXQ devices
openFDA lists no recalls for product code FXQ.
Frequently asked questions
What is FDA product code FXQ?
FXQ is the FDA product code for lens, camera, surgical. It is a Class I device, regulated under 21 CFR 878.4160 and reviewed by the General and Plastic Surgery panel.
What device class is FXQ?
Class I, regulation 21 CFR 878.4160. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code FXQ?
Across 1 cleared submissions the average was 30 days from receipt to decision (median 30).
Which companies have the most FXQ clearances?
Kelleher Corp. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code FXQ
- Run a recall and safety report across every FXQ manufacturer
- Watch product code FXQ 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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