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PID — Esophageal Dilator Balloon With Or Without Electrode Sensors Class II

FDA Device Classification

Classification Details

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

Definition

To dilate the lower esophageal sphincter of patients with Achalasia.

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K182895wilson-cook medicalWilson-Cook Achalasia BalloonJanuary 25, 2019
K132337crosponESOFLIP BALLOON DILATION CATHETEROctober 7, 2013
K050232boston scientificRIGIFLEX SINGLE-USE ACHALASIA BALLOON DILATORMarch 11, 2005