Product code PID— Gastroenterology, Urology

ESOFLIP BALLOON DILATION CATHETER

Classification name: Esophageal Dilator Balloon With Or Without Electrode Sensors
Device class: Class 2
Regulation: 21 CFR 876.5980
Advisory panel: Gastroenterology, Urology
Total cleared: 3
First cleared: 2005-03-11
Most recent: 2019-01-25

FDA classification definition

“To dilate the lower esophageal sphincter of patients with Achalasia.”
— U.S. Food and Drug Administration, device classification record for product code PID under 21 CFR 876.5980, via openFDA

Market context for product code PID

FDA has cleared 3 devices under product code PID between 2005 and 2019, filed by 3 applicant companies. 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

20191 clearance
20131 clearance
20051 clearance

Top applicants under product code PID

Recent clearances under product code PID

K182895 — Wilson-Cook Achalasia BalloonWilson-Cook Medical, Inc.·2019-01-25
K132337 — ESOFLIP BALLOON DILATION CATHETERCrospon, Ltd.·2013-10-07
K050232 — RIGIFLEX SINGLE-USE ACHALASIA BALLOON DILATORBoston Scientific Corp·2005-03-11

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