Product code QTH

Device name

Endoscopic Light-Projecting Measuring Device

Medical specialty

Gastroenterology, Urology

Device class

2

Regulation number

876.1530

Review panel

GU

Implant

N

Life sustaining/supporting

N

GMP exempt

N

Third party review

N

Summary malfunction reporting

Ineligible

Definition

An endoscopic light-projecting measuring device projects light on a mucosal surface and uses software to determine the dimensions of observable features of interest.

Source

FDA openFDA device classification dataset