Cleared Traditional

K142000 - ESOFLIP ES (FDA 510(k) Clearance)

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

K142000 · Crospon, Ltd. · Gastroenterology & Urology device
Sep 2014
Decision
64d
Days
Class 2
Risk

K142000 is an FDA 510(k) clearance for the ESOFLIP ES. Classified as Esophageal Dilator With Balloon And Electrode Sensors (product code PIE), Class II - Special Controls.

Submitted by Crospon, Ltd. (Bonita Springs, US). The FDA issued a Cleared decision on September 25, 2014 after a review of 64 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 K142000 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 23, 2014
Decision Date September 25, 2014
Days to Decision 64 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Regulatory Context
Review time vs. panel average
92d faster than avg
Panel avg: 156d · This submission: 64d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code PIE Esophageal Dilator With Balloon And Electrode Sensors
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5980
Definition To Dilate Esophageal Strictures With A Dilating Balloon And Electrode Sensors.
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.