FCY

Bulb, Inflation, For Endoscope

Product code

FCY

Device name

Bulb, Inflation, For Endoscope

Device class

Class 1

21 CFR

21 CFR 876.1500

Medical specialty

Gastroenterology, Urology

Marketing pathway

510(K) Exempt

510(k) clearances (all years, FDA)

3 (all years; only the last 3 years are listed here)

FDA classification definition

An endoscope bulb pressurizes the interior of an endoscope. The user identifies the presence of leaks in the endoscope by immersing in water and visually observing for bubbles.

Definition text from the FDA device classification database (U.S. federal government work, public domain).