FDA product code FTX: Mirror, General & Plastic Surgery
FTX is the FDA product code for mirror, general & plastic surgery. It is a Class I device, regulated under 21 CFR 878.4800 and reviewed by the General and Plastic Surgery panel. FDA has cleared 1 510(k) submission under FTX. The average 510(k) review took 34 days (median 34).
Classification
| Field | Value |
|---|---|
| Device name | Mirror, General & Plastic Surgery |
| Device class | Class I |
| Regulation | 21 CFR 878.4800 |
| 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 FTX clearance
Top FTX applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Lifestream Int'L, Inc. | 1 | 1987-04-01 |
Most recent FTX clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K870790 | Lifestream Int'L, Inc. | REFLECTIVE MIRROR/CO2 LASER SURG CAT. #902002-000 | 1987-04-01 | 34 |
Recalls for FTX devices
openFDA lists no recalls for product code FTX.
Frequently asked questions
What is FDA product code FTX?
FTX is the FDA product code for mirror, general & plastic surgery. It is a Class I device, regulated under 21 CFR 878.4800 and reviewed by the General and Plastic Surgery panel.
What device class is FTX?
Class I, regulation 21 CFR 878.4800. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code FTX?
Across 1 cleared submissions the average was 34 days from receipt to decision (median 34).
Which companies have the most FTX clearances?
Lifestream Int'L, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code FTX
- Run a recall and safety report across every FTX manufacturer
- Watch product code FTX 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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