Cleared Special

RIGIFLEX SINGLE-USE ACHALASIA BALLOON DILATOR

K050232 · Boston Scientific Corp · Gastroenterology & Urology

Mar 2005

Decision

38d

Days

Class 2

Risk

About This 510(k) Submission

K050232 is an FDA 510(k) clearance for the RIGIFLEX SINGLE-USE ACHALASIA BALLOON DILATOR, a Esophageal Dilator Balloon With Or Without Electrode Sensors (Class II — Special Controls, product code PID), submitted by Boston Scientific Corp (Natick, US). The FDA issued a Cleared decision on March 11, 2005, 38 days after receiving the submission on February 1, 2005. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5980.

Submission Details

510(k) Number	K050232 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 01, 2005
Decision Date	March 11, 2005
Days to Decision	38 days
Submission Type	Special
Review Panel	Gastroenterology & Urology (GU)
Summary	Summary PDF

Device Classification

Product Code	PID — Esophageal Dilator Balloon With Or Without Electrode Sensors
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 876.5980
Definition	To Dilate The Lower Esophageal Sphincter Of Patients With Achalasia.