Cleared Traditional

K150558 - Eclipse System

K150558 is an FDA 510(k) clearance for Eclipse System, manufactured by Pelvalon, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code PJH cleared through the Traditional 510(k) pathway after a 253-day FDA review.

K150558 · Pelvalon, Inc. · Gastroenterology & Urology device
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Nov 2015
Decision
253d
Days
Class 2
Risk

K150558 is an FDA 510(k) clearance for the Eclipse System. Classified as Dynamic Rectal Control System (product code PJH), Class II - Special Controls.

Submitted by Pelvalon, Inc. (Sunnyvale, US). The FDA issued a Cleared decision on November 12, 2015 after a review of 253 days - an extended review cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5930 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all Pelvalon, Inc. devices

FDA 510(k) Submission Details - K150558

510(k) Number K150558 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 04, 2015
Decision Date November 12, 2015
Days to Decision 253 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
123d slower than avg
Panel avg: 130d · This submission: 253d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

PJH Device Classification - Class 2, Special Controls

Product Code PJH Dynamic Rectal Control System
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5930
Definition Intended To Treat Fecal Incontinence By Controlling The Size Of The Rectal Lumen.
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.