FDA product code FEH: Electrode, Flexible Suction Coagulator
FEH is the FDA product code for electrode, flexible suction coagulator. It is a Class II device, regulated under 21 CFR 876.4300 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 3 510(k) submissions under FEH, from 2 different applicants. The average 510(k) review took 34 days (median 28).
Classification
| Field | Value |
|---|---|
| Device name | Electrode, Flexible Suction Coagulator |
| Device class | Class II |
| Regulation | 21 CFR 876.4300 |
| 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 FEH clearance
Top FEH applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Optim, LLC | 2 | 2013-04-19 |
| American Cystocope Makers, Inc. | 1 | 1981-01-15 |
Most recent FEH clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K130489 | Optim, LLC | ELECTRODE, FLEXIBLE SUCTION COAGULATOR | 2013-04-19 | 53 |
| K122593 | Optim, LLC | PRECISION ENDOSCOPIC INFRARED COAGULATOR; MODEL 5100 SINGLE-USE DISPOSABLE MAXI-GUIDE FLEXIBLE LIGHTGUIDE; MODEL 5100-2 | 2012-09-13 | 20 |
| K803214 | American Cystocope Makers, Inc. | ACMI BIPOLAR HEMOSTATIC ELECTRODE | 1981-01-15 | 28 |
Recalls for FEH devices
openFDA lists no recalls for product code FEH.
Frequently asked questions
What is FDA product code FEH?
FEH is the FDA product code for electrode, flexible suction coagulator. It is a Class II device, regulated under 21 CFR 876.4300 and reviewed by the Gastroenterology and Urology panel.
What device class is FEH?
Class II, regulation 21 CFR 876.4300. Typical premarket route: 510(k).
How long does a 510(k) take for product code FEH?
Across 3 cleared submissions the average was 34 days from receipt to decision (median 28).
Which companies have the most FEH clearances?
Optim, LLC (2); American Cystocope Makers, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code FEH
- Run a recall and safety report across every FEH manufacturer
- Watch product code FEH 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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