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PIE — Esophageal Dilator With Balloon And Electrode Sensors Class II

FDA Device Classification

Classification Details

Product Code
PIE
Device Class
Class II
Regulation Number
876.5980
Submission Type
Review Panel
GU
Medical Specialty
Gastroenterology, Urology
Implant
No

Definition

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

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K172128crosponEsoFLIP® ES-310 Balloon CatheterNovember 22, 2017
K142000crosponESOFLIP ESSeptember 25, 2014