Cleared Traditional

K192898 - PneumoLiner (FDA 510(k) Clearance)

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

K192898 · Advanced Surgical Concepts · Obstetrics & Gynecology device
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Feb 2020
Decision
137d
Days
Class 2
Risk

K192898 is an FDA 510(k) clearance 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 (Bray, IE). The FDA issued a Cleared decision on February 25, 2020 after a review of 137 days - within the typical 510(k) review window.

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 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 Obstetrics & Gynecology review framework, consistent with the majority of Class II 510(k) submissions.

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Submission Details

510(k) Number K192898 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 11, 2019
Decision Date February 25, 2020
Days to Decision 137 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
23d faster than avg
Panel avg: 160d · This submission: 137d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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.