DeviceClearance

Product code FCW— Gastroenterology, Urology

50 W METAL HALIDE ILLUMINATOR, VES 0501.

Classification name
Light Source, Fiberoptic, Routine
Device class
Class 2
Regulation
21 CFR 876.1500
Advisory panel
Gastroenterology, Urology
Total cleared
31
First cleared
Most recent

Market context for product code FCW

FDA has cleared 31 devices under product code FCW between 1976 and 2014, filed by 27 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

last 15 years

Top applicants under product code FCW

Adverse events under product code FCW

product code FCW
Malfunction
912
Other
1
Total
913

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recent clearances under product code FCW

Data sourced from openFDA. This site is unofficial and independent of the FDA.