DeviceClearance

Product code PIE— Gastroenterology, Urology

ESOFLIP ES

Classification name
Esophageal Dilator With Balloon And Electrode Sensors
Device class
Class 2
Regulation
21 CFR 876.5980
Advisory panel
Gastroenterology, Urology
Total cleared
2
First cleared
Most recent

FDA classification definition

“To dilate esophageal strictures with a dilating balloon and electrode sensors.”

— U.S. Food and Drug Administration, device classification record for product code PIE under 21 CFR 876.5980, via openFDA

Market context for product code PIE

FDA has cleared 2 devices under product code PIE between 2014 and 2017, 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.

Clearances per year

Top applicants under product code PIE

Recent clearances under product code PIE

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