DeviceClearance

Product code FCX— Gastroenterology, Urology

BAROnova Insufflation System, BAROnova Accessory Kit

Classification name
Insufflator, Automatic Carbon-Dioxide For Endoscope
Device class
Class 2
Regulation
21 CFR 876.1500
Advisory panel
Gastroenterology, Urology
Total cleared
25
First cleared
Most recent

Market context for product code FCX

FDA has cleared 25 devices under product code FCX between 1985 and 2026, filed by 19 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 FCX

Recent clearances under product code FCX

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