FDA product code FCR: Light Source, Photographic, Fiberoptic
FCR is the FDA product code for light source, photographic, fiberoptic. It is a Class II device, regulated under 21 CFR 876.1500 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 3 510(k) submissions under FCR, from 2 different applicants. The average 510(k) review took 50 days (median 9).
Classification
| Field | Value |
|---|---|
| Device name | Light Source, Photographic, Fiberoptic |
| Device class | Class II |
| Regulation | 21 CFR 876.1500 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) exempt |
Top FCR applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Warner-Lambert Co. | 2 | 1982-06-24 |
| Mecron Medical Products, Inc. | 1 | 1985-04-22 |
Most recent FCR clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K844774 | Mecron Medical Products, Inc. | EFFNER FIBER OPTIC CABLES FOR COLD LIGHT TRANSMISS | 1985-04-22 | 133 |
| K821754 | Warner-Lambert Co. | A O FIBER OPTIC ILLUMINATOR, 1185B | 1982-06-24 | 9 |
| K821753 | Warner-Lambert Co. | A O FIBER OPTIC ILLUMINATION, 1185A | 1982-06-24 | 9 |
Recalls for FCR devices
openFDA lists no recalls for product code FCR.
Frequently asked questions
What is FDA product code FCR?
FCR is the FDA product code for light source, photographic, fiberoptic. It is a Class II device, regulated under 21 CFR 876.1500 and reviewed by the Gastroenterology and Urology panel.
What device class is FCR?
Class II, regulation 21 CFR 876.1500. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code FCR?
Across 3 cleared submissions the average was 50 days from receipt to decision (median 9).
Which companies have the most FCR clearances?
Warner-Lambert Co. (2); Mecron Medical Products, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code FCR
- Run a recall and safety report across every FCR manufacturer
- Watch product code FCR 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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