FDA product code FTG: Illuminator, Remote
FTG is the FDA product code for illuminator, remote. It is a Class II device, regulated under 21 CFR 878.4580 and reviewed by the General and Plastic Surgery panel. FDA has cleared 2 510(k) submissions under FTG, from 2 different applicants. The average 510(k) review took 66 days (median 66).
Classification
| Field | Value |
|---|---|
| Device name | Illuminator, Remote |
| Device class | Class II |
| Regulation | 21 CFR 878.4580 |
| 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 FTG clearance
Top FTG applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Int'L Marketing & Sales Corp. | 1 | 1980-08-07 |
| Cobe Laboratories, Inc. | 1 | 1976-11-19 |
Most recent FTG clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K801065 | Int'L Marketing & Sales Corp. | NIKKISO PARALLEL FLOW DIALYZERS | 1980-08-07 | 93 |
| K760815 | Cobe Laboratories, Inc. | FITTING/DIALYZER | 1976-11-19 | 38 |
Recalls for FTG devices
openFDA lists no recalls for product code FTG.
Frequently asked questions
What is FDA product code FTG?
FTG is the FDA product code for illuminator, remote. It is a Class II device, regulated under 21 CFR 878.4580 and reviewed by the General and Plastic Surgery panel.
What device class is FTG?
Class II, regulation 21 CFR 878.4580. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code FTG?
Across 2 cleared submissions the average was 66 days from receipt to decision (median 66).
Which companies have the most FTG clearances?
Int'L Marketing & Sales Corp. (1); Cobe Laboratories, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code FTG
- Run a recall and safety report across every FTG manufacturer
- Watch product code FTG 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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