FDA product code FXM: Camera, Still, Endoscopic
FXM is the FDA product code for camera, still, endoscopic. 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 FXM. The average 510(k) review took 28 days (median 28). FDA has posted 5 recalls for FXM devices.
Classification
| Field | Value |
|---|---|
| Device name | Camera, Still, Endoscopic |
| 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 FXM clearance
Top FXM applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Kelleher Corp. | 1 | 1982-08-20 |
Most recent FXM clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K822167 | Kelleher Corp. | STILL ENDOSCOPIC CAMERAS | 1982-08-20 | 28 |
Recalls for FXM devices
5 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2004-02-19.
Frequently asked questions
What is FDA product code FXM?
FXM is the FDA product code for camera, still, endoscopic. 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 FXM?
Class I, regulation 21 CFR 878.4160. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code FXM?
Across 1 cleared submissions the average was 28 days from receipt to decision (median 28).
Which companies have the most FXM clearances?
Kelleher Corp. (1).
Have FXM devices been recalled?
Yes: 5 product recalls across 1 recall events; the most recent began 2004-02-19.
Next steps
- Run an FDA pathway report with predicate devices for product code FXM
- Run a recall and safety report across every FXM manufacturer
- Watch product code FXM 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 General and Plastic Surgery product codes · FDA product code lookup · 510(k) database search · 510(k) review times