Cleared Traditional

K132337 - ESOFLIP BALLOON DILATION CATHETER (FDA 510(k) Clearance)

Class II Gastroenterology & Urology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K132337 · Crospon, Ltd. · Gastroenterology & Urology device
Oct 2013
Decision
73d
Days
Class 2
Risk

K132337 is an FDA 510(k) clearance for the ESOFLIP BALLOON DILATION CATHETER. Classified as Esophageal Dilator Balloon With Or Without Electrode Sensors (product code PID), Class II - Special Controls.

Submitted by Crospon, Ltd. (Bonita Springs, US). The FDA issued a Cleared decision on October 7, 2013 after a review of 73 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

Submission Details

510(k) Number K132337 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 26, 2013
Decision Date October 07, 2013
Days to Decision 73 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Regulatory Context
Review time vs. panel average
83d faster than avg
Panel avg: 156d · This submission: 73d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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.