Product code FCR— Gastroenterology, Urology
A O FIBER OPTIC ILLUMINATION, 1185A
- Classification name
- Light Source, Photographic, Fiberoptic
- Device class
- Class 2
- Regulation
- 21 CFR 876.1500
- Advisory panel
- Gastroenterology, Urology
- Total cleared
- 3
- First cleared
- Most recent
Market context for product code FCR
FDA has cleared devices under product code FCR between 1982 and 1985, filed by 2 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
- 1985
- 1982
Top applicants under product code FCR
Recent clearances under product code FCR
Data sourced from openFDA. This site is unofficial and independent of the FDA.