FDA product code FAN: Sigmoidoscope, Rigid, Electrical
FAN is the FDA product code for sigmoidoscope, rigid, electrical. 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 FAN, 1 in the last five years, from 2 different applicants. The average 510(k) review took 112 days (median 112).
Classification
| Field | Value |
|---|---|
| Device name | Sigmoidoscope, Rigid, Electrical |
| Device class | Class II |
| Regulation | 21 CFR 876.1500 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) |
510(k) clearances per year for FAN
| Year | Clearances | Avg. review days |
|---|---|---|
| 2023 | 1 | 122 |
Compare with all 510(k) review times · Search every FAN clearance
Top FAN applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Surgease Innovations Limited | 1 | 2023-11-30 |
| C.R. Bard, Inc. | 1 | 1983-09-12 |
Most recent FAN clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K232262 | Surgease Innovations Limited | LumenEye® X1 endoscope (LX1-SCP-203); LumenEye® X1 consumables (LX1-CSB-201); LumenEye® X1 Consumable Carton (25 Sets) (LX1-CSP-201 ) | 2023-11-30 | 122 |
| K831788 | C.R. Bard, Inc. | URODYNAMIC ANALYZER | 1983-09-12 | 101 |
Recalls for FAN devices
openFDA lists no recalls for product code FAN.
Frequently asked questions
What is FDA product code FAN?
FAN is the FDA product code for sigmoidoscope, rigid, electrical. It is a Class II device, regulated under 21 CFR 876.1500 and reviewed by the Gastroenterology and Urology panel.
What device class is FAN?
Class II, regulation 21 CFR 876.1500. Typical premarket route: 510(k).
How long does a 510(k) take for product code FAN?
Across 2 cleared submissions the average was 112 days from receipt to decision (median 112).
Which companies have the most FAN clearances?
Surgease Innovations Limited (1); C.R. Bard, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code FAN
- Run a recall and safety report across every FAN manufacturer
- Watch product code FAN 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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