FDA product code FTS: Camera, Cine, Endoscopic, With Audio
FTS is the FDA product code for camera, cine, endoscopic, with audio. It is a Class I device, regulated under 21 CFR 878.4160 and reviewed by the General and Plastic Surgery panel. FDA has cleared 2 510(k) submissions under FTS. The average 510(k) review took 9 days (median 9).
Classification
| Field | Value |
|---|---|
| Device name | Camera, Cine, Endoscopic, With Audio |
| 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 FTS clearance
Top FTS applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Medical Concepts, Inc. | 2 | 1988-09-28 |
Most recent FTS clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K883943 | Medical Concepts, Inc. | CCM-1 VIDEO CAMERA SYSTEM | 1988-09-28 | 9 |
| K883944 | Medical Concepts, Inc. | MEC-1 VIDEO COMBO SYSTEM | 1988-09-28 | 9 |
Recalls for FTS devices
openFDA lists no recalls for product code FTS.
Frequently asked questions
What is FDA product code FTS?
FTS is the FDA product code for camera, cine, endoscopic, with audio. 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 FTS?
Class I, regulation 21 CFR 878.4160. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code FTS?
Across 2 cleared submissions the average was 9 days from receipt to decision (median 9).
Which companies have the most FTS clearances?
Medical Concepts, Inc. (2).
Next steps
- Run an FDA pathway report with predicate devices for product code FTS
- Run a recall and safety report across every FTS manufacturer
- Watch product code FTS 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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