FDA product code FTI: Lamp, Endoscope, Incandescent
FTI is the FDA product code for lamp, endoscope, incandescent. It is a Class II device, regulated under 21 CFR 876.1500 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 2 510(k) submissions under FTI, from 2 different applicants. The average 510(k) review took 220 days (median 220).
Classification
| Field | Value |
|---|---|
| Device name | Lamp, Endoscope, Incandescent |
| Device class | Class II |
| Regulation | 21 CFR 876.1500 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every FTI clearance
Top FTI applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Clarus Medical Systems, Inc. | 1 | 1997-05-20 |
| Dia-Stron, Ltd. | 1 | 1992-11-16 |
Most recent FTI clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K971455 | Clarus Medical Systems, Inc. | CLARUS MODEL 5197 SIGHTLITE | 1997-05-20 | 29 |
| K914397 | Dia-Stron, Ltd. | OXFORD OPTRONIX MPM 3S | 1992-11-16 | 412 |
Recalls for FTI devices
openFDA lists no recalls for product code FTI.
Frequently asked questions
What is FDA product code FTI?
FTI is the FDA product code for lamp, endoscope, incandescent. It is a Class II device, regulated under 21 CFR 876.1500 and reviewed by the Gastroenterology and Urology panel.
What device class is FTI?
Class II, regulation 21 CFR 876.1500. Typical premarket route: 510(k).
How long does a 510(k) take for product code FTI?
Across 2 cleared submissions the average was 220 days from receipt to decision (median 220).
Which companies have the most FTI clearances?
Clarus Medical Systems, Inc. (1); Dia-Stron, Ltd. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code FTI
- Run a recall and safety report across every FTI manufacturer
- Watch product code FTI 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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