FDA product code FEI: Instrument, Special Lens, For Endoscope
FEI is the FDA product code for instrument, special lens, for endoscope. It is a Class I device, regulated under 21 CFR 876.1500 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 2 510(k) submissions under FEI, from 2 different applicants. The average 510(k) review took 102 days (median 102). FDA has posted 2 recalls for FEI devices.
Classification
| Field | Value |
|---|---|
| Device name | Instrument, Special Lens, For Endoscope |
| Device class | Class I |
| Regulation | 21 CFR 876.1500 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every FEI clearance
Top FEI applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Opto Vision, Inc. | 1 | 1988-01-14 |
| American Edwards Laboratories | 1 | 1986-10-24 |
Most recent FEI clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K873795 | Opto Vision, Inc. | M-LENS (THIRTY DEGREE ENDOSCOPE) | 1988-01-14 | 119 |
| K862872 | American Edwards Laboratories | FLEXIBLE VISUALIZATION CATHETER | 1986-10-24 | 86 |
Recalls for FEI devices
2 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2016-10-04.
Frequently asked questions
What is FDA product code FEI?
FEI is the FDA product code for instrument, special lens, for endoscope. It is a Class I device, regulated under 21 CFR 876.1500 and reviewed by the Gastroenterology and Urology panel.
What device class is FEI?
Class I, regulation 21 CFR 876.1500. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code FEI?
Across 2 cleared submissions the average was 102 days from receipt to decision (median 102).
Which companies have the most FEI clearances?
Opto Vision, Inc. (1); American Edwards Laboratories (1).
Have FEI devices been recalled?
Yes: 2 product recalls across 1 recall events; the most recent began 2016-10-04.
Next steps
- Run an FDA pathway report with predicate devices for product code FEI
- Run a recall and safety report across every FEI manufacturer
- Watch product code FEI 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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