DeviceClearance

Product code PMU— Obstetrics/Gynecology

PneumoLiner

Classification name
Containment System, Laparoscopic Power Morcellation, With Instrument Port
Device class
Class 2
Regulation
21 CFR 884.4050
Advisory panel
Obstetrics/Gynecology
Total cleared
4
First cleared
Most recent

FDA classification 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.”

— U.S. Food and Drug Administration, device classification record for product code PMU under 21 CFR 884.4050, via openFDA

Market context for product code PMU

FDA has cleared 4 devices under product code PMU between 2016 and 2025, filed by 4 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code PMU

Recent clearances under product code PMU

Data sourced from openFDA. This site is unofficial and independent of the FDA.