# K212659: More-Cell-System

- Pathway: 510(k) (Traditional)
- Applicant: Agency For Medical Innovations GmbH
- Decided: Nov 10, 2021 after 79 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
Longest line of descent: 2 generations back to DEN150028 (2016). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K192898: PneumoLiner, Advanced Surgical Concepts (2020) Summary page 4.

## Indications for use
More-Cell-System is intended for use as a tissue containment system during minimally invasive gynecologic laparoscopic surgery to enable the isolation and containment of tissue considered benign, resected during multi-site laparoscopic surgery for power morcellation and removal. When used in women with fibroids, the More-Cell System is for women who are pre-menopausal and under age 50. More-Cell-System is compatible with electromechanical laparoscopic power morcellators that are between 12 mm and 20 mm in shaft outer diameter and between 95 mm and 170 mm in shaft working length.

Source page: https://510kreport.com/device/K212659
Methodology: https://510kreport.com/methodology