PneumoLiner

FDA 510(k) K192898 · Advanced Surgical Concepts

Substantially Equivalent

510(k) numberK192898

Submission

Device name
PneumoLiner
Applicant
Advanced Surgical Concepts
Bray, IE
Received
October 11, 2019
Decision date
February 25, 2020
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
PMU – Containment System, Laparoscopic Power Morcellation, With Instrument Port
Device class
Class II (moderate risk)
Regulation
21 CFR 884.4050
Specialty
Obstetrics/Gynecology

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…

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K250212LapBox Power Tissue Containment SystemPMU · Traditional Ark Surgical04/15/2025SE
K212659More-Cell-SystemPMU · Traditional Agency For Medical Innovations GmbH11/10/2021SE

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Questions and answers

When was PneumoLiner cleared by the FDA?

PneumoLiner (K192898) received a 510(k) decision of Substantially Equivalent on February 25, 2020, 137 days after the submission was received.

What is the product code of K192898?

The FDA product code is PMU – Containment System, Laparoscopic Power Morcellation, With Instrument Port, a Class II (moderate risk) device regulated under 21 CFR 884.4050.