FDA product code FEA: Attachment, Teaching, For Endoscope
FEA is the FDA product code for attachment, teaching, 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 FEA, from 2 different applicants. The average 510(k) review took 72 days (median 72).
Classification
| Field | Value |
|---|---|
| Device name | Attachment, Teaching, 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 FEA clearance
Top FEA applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Jedmed Instrument Co. | 1 | 1994-02-18 |
| American Optical Corp. | 1 | 1979-09-24 |
Most recent FEA clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K935247 | Jedmed Instrument Co. | JEDMED COMPACT ENDOSCOPIC BEAMSPLITTER | 1994-02-18 | 109 |
| K791635 | American Optical Corp. | AO TEACHING ATTACHMENT, MODEL TA-1 | 1979-09-24 | 34 |
Recalls for FEA devices
openFDA lists no recalls for product code FEA.
Frequently asked questions
What is FDA product code FEA?
FEA is the FDA product code for attachment, teaching, 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 FEA?
Class I, regulation 21 CFR 876.1500. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code FEA?
Across 2 cleared submissions the average was 72 days from receipt to decision (median 72).
Which companies have the most FEA clearances?
Jedmed Instrument Co. (1); American Optical Corp. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code FEA
- Run a recall and safety report across every FEA manufacturer
- Watch product code FEA 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.
All Gastroenterology and Urology product codes · FDA product code lookup · 510(k) database search · 510(k) review times