# K192898: PneumoLiner

- Pathway: 510(k) (Traditional)
- Applicant: Advanced Surgical Concepts
- Decided: Feb 25, 2020 after 137 days
- Product code: PMU (Containment System, Laparoscopic Power Morcellation, With Instrument Port)
- Device class: 2
- Regulation: 21 CFR 884.4050
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to DEN150028 (2016). 1 ancestor in all.
2 later devices descend from it; 2 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- DEN150028: PneumoLiner, Advanced Surgical Concepts, Ltd. (2016) Summary page 4.

## Most influential descendants
- K250212: LapBox Power Tissue Containment System (2025), 0 descendants of its own
- K212659: More-Cell-System (2021), 0 descendants of its own

## Recalls of this device
- Sep 21, 2021 · Class II · Z-0176-2022: Due to manufacturing error, the Pneumoliner Bag Distal Tab that exits the Introducer shaft is in the wrong orientation. This results in the user deploying the bag upside down, which will make tissue e

## Indications for use
The PneumoLiner device is intended for 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. When used in women with fibroids, the PneumoLiner is for women who are pre-menopausal and under age 50. The PneumoLiner is compatible with bipolar or electromechanical laparoscopic power morcellators that are between 15mm and 18mm in shaft outer diameter and 135mm and 180mm in shaft working length and which have an external component that allows for the proper orientation of the laparoscope to perform a contained morcellation.

Source page: https://510kreport.com/device/K192898
Methodology: https://510kreport.com/methodology