DeviceClearance

Product code PGU— Gastroenterology, Urology

ENDOSCOPE POSITION MARKING PROBE,ENDOSCOPE POSITION DETECTING UNIT

Classification name
Spatial Imaging For Display Of Endoscope Position
Device class
Class 2
Regulation
21 CFR 876.1500
Advisory panel
Gastroenterology, Urology
Total cleared
1
First cleared
Most recent

FDA classification definition

“To detect and display the shape of an inserted endoscope.”

— U.S. Food and Drug Administration, device classification record for product code PGU under 21 CFR 876.1500, via openFDA

Market context for product code PGU

FDA has cleared 1 device under product code PGU, all in 2014, filed by 1 applicant company. 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.

Top applicants under product code PGU

Recent clearances under product code PGU

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