# DEN150028: PneumoLiner

- Pathway: De Novo (Direct)
- Applicant: Advanced Surgical Concepts, Ltd.
- Decided: Apr 7, 2016 after 293 days
- Product code: PMU (Containment System, Laparoscopic Power Morcellation, With Instrument Port)
- Device class: 2
- Regulation: 21 CFR 884.4050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
3 later devices descend from it; 1 cites 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)
- None. De Novo decisions do not claim a predicate device.

## Most influential descendants
- K192898: PneumoLiner (2020), 2 descendants of its own
- K250212: LapBox Power Tissue Containment System (2025), 0 descendants of its own
- K212659: More-Cell-System (2021), 0 descendants of its own

## Indications for use
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 PneumoLiner 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.

Source page: https://510kreport.com/device/DEN150028
Methodology: https://510kreport.com/methodology