Product code FCY

Device name

Bulb, Inflation, For Endoscope

Medical specialty

Gastroenterology, Urology

Device class

1

Regulation number

876.1500

Review panel

GU

Implant

N

Life sustaining/supporting

N

GMP exempt

N

Third party review

N

Summary malfunction reporting

Eligible

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.

Source

FDA openFDA device classification dataset