PMU — Containment System, Laparoscopic Power Morcellation, With Instrument Port Class II

FDA Device Classification

Classification Details

Product Code
PMU
Device Class
Class II
Regulation Number
884.4050
Submission Type
Review Panel
OB
Medical Specialty
Obstetrics/Gynecology
Implant
No

Definition

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 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.

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K250212ark surgicalLapBox Power Tissue Containment SystemApril 15, 2025
K212659agency for medical innovationsMore-Cell-SystemNovember 10, 2021
K192898advanced surgical conceptsPneumoLinerFebruary 25, 2020
DEN150028advanced surgical conceptsPneumoLinerApril 7, 2016