# K250212: LapBox Power Tissue Containment System

- Pathway: 510(k) (Traditional)
- Applicant: Ark Surgical
- Decided: Apr 15, 2025 after 81 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 5.

## Indications for use
The LapBox Power Tissue Containment System 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. The LapBox is compatible with 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. When used in women with fibroids, the LapBox Power Tissue Containment System is for women who are pre-menopausal and under age 50.

Source page: https://510kreport.com/device/K250212
Methodology: https://510kreport.com/methodology