Cleared Traditional

K150558 - Eclipse System (FDA 510(k) Clearance)

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

K150558 · Pelvalon, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

Submission Details

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.

Device Classification

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.