PGU

Spatial Imaging For Display Of Endoscope Position

Product code

PGU

Device name

Spatial Imaging For Display Of Endoscope Position

Device class

Class 2

21 CFR

21 CFR 876.1500

Medical specialty

Gastroenterology, Urology

Marketing pathway

510(K)

510(k) clearances (all years, FDA)

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

FDA classification definition

To detect and display the shape of an inserted endoscope.

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