Not Cleared Direct

DEN150028 - PneumoLiner (FDA 510(k) Clearance)

Class II Obstetrics & Gynecology device cleared through the Direct 510(k) pathway - typically does not require clinical trials.

DEN150028 · Advanced Surgical Concepts, Ltd. · Obstetrics & Gynecology device
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Apr 2016
Decision
293d
Days
Class 2
Risk

DEN150028 is an FDA 510(k) submission (not cleared) for the PneumoLiner. Classified as Containment System, Laparoscopic Power Morcellation, With Instrument Port (product code PMU), Class II - Special Controls.

Submitted by Advanced Surgical Concepts, Ltd. (Bray, IE). The FDA issued a Not Cleared (DENG) decision on April 7, 2016 after a review of 293 days.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.4050 - the FDA obstetrics and gynecology device framework. The Traditional 510(k) pathway requires demonstration of substantial equivalence to a legally marketed predicate device - a standard the FDA determined was not met in this submission.

Device pattern: Regulatory edge-case submission. Elevated predicate reliance profile. With 293 days under review and no clearance granted, this submission reflects a case where the FDA could not confirm sufficient predicate equivalence - often indicating either a novel device category or unresolved safety and performance questions.

View all Advanced Surgical Concepts, Ltd. devices

Submission Details

510(k) Number DEN150028 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received June 19, 2015
Decision Date April 07, 2016
Days to Decision 293 days
Submission Type Direct
Review Panel Obstetrics & Gynecology (OB)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
133d slower than avg
Panel avg: 160d · This submission: 293d
Pathway characteristics

Device Classification

Product Code PMU Containment System, Laparoscopic Power Morcellation, With Instrument Port
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.4050
Definition Use As A Multiple Instrument Port And Tissue Containment System During Minimally Invasive Gynecologic Laparoscopic Surgery To Enable The Isolation And Containment Of Tissue Considered Benign, Resected During Single-port Or Multi-site Laparoscopic Surgery During Power Morcellation And Removal. The Device Is Compatible With Bipolar Or Electromechanical Laparoscopic Power Morcellators That Are Between 15 Mm And 18 Mm In Shaft Outer Diameter And 135 Mm And 180 Mm In Shaft Working Length And Which Have An External Component That Allows For The Proper Orientation Of The Laparoscope To Perform A Contained Morcellation.
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 Obstetrics & Gynecology devices follow this clearance model.