Cleared Special

K050232 - RIGIFLEX SINGLE-USE ACHALASIA BALLOON DILATOR

K050232 is an FDA 510(k) clearance for RIGIFLEX SINGLE-USE ACHALASIA BALLOON D..., manufactured by Boston Scientific Corp. The device is a Class 2 Gastroenterology & Urology device with product code PID cleared through the Special 510(k) pathway after a 38-day FDA review.

K050232 · Boston Scientific Corp · Gastroenterology & Urology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2005
Decision
38d
Days
Class 2
Risk

K050232 is an FDA 510(k) clearance for the RIGIFLEX SINGLE-USE ACHALASIA BALLOON DILATOR. Classified as Esophageal Dilator Balloon With Or Without Electrode Sensors (product code PID), Class II - Special Controls.

Submitted by Boston Scientific Corp (Natick,, US). The FDA issued a Cleared decision on March 11, 2005 after a review of 38 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5980 - the FDA gastroenterology and urology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K050232

510(k) Number K050232 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
93d faster than avg
Panel avg: 131d · This submission: 38d
Pathway characteristics
Modification to existing cleared device.

PID Device Classification - Class 2, Special Controls

Product Code PID Esophageal Dilator Balloon With Or Without Electrode Sensors
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5980
Definition To Dilate The Lower Esophageal Sphincter Of Patients With Achalasia.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Gastroenterology & Urology devices follow this clearance model.

K050232 · RIGIFLEX SINGLE-USE ACHALASIA BALLOON DILATOR
Download PDF FDA Summary Boston Scientific Corp