FDA product code FFI: System, Alarm, Electrosurgical
FFI is the FDA product code for system, alarm, electrosurgical. It is a Class II device, regulated under 21 CFR 876.4300 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 1 510(k) submission under FFI. The average 510(k) review took 106 days (median 106).
Classification
| Field | Value |
|---|---|
| Device name | System, Alarm, Electrosurgical |
| 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 FFI clearance
Top FFI applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Akron City Hospital | 1 | 1984-11-29 |
Most recent FFI clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K843214 | Akron City Hospital | EPHAR | 1984-11-29 | 106 |
Recalls for FFI devices
openFDA lists no recalls for product code FFI.
Frequently asked questions
What is FDA product code FFI?
FFI is the FDA product code for system, alarm, electrosurgical. It is a Class II device, regulated under 21 CFR 876.4300 and reviewed by the Gastroenterology and Urology panel.
What device class is FFI?
Class II, regulation 21 CFR 876.4300. Typical premarket route: 510(k).
How long does a 510(k) take for product code FFI?
Across 1 cleared submissions the average was 106 days from receipt to decision (median 106).
Which companies have the most FFI clearances?
Akron City Hospital (1).
Next steps
- Run an FDA pathway report with predicate devices for product code FFI
- Run a recall and safety report across every FFI manufacturer
- Watch product code FFI 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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