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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device containment system, laparoscopic power morcellation, with instrument port
Regulation Description Gynecologic laparoscopic power morcellation containment system.
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.
Product CodePMU
Regulation Number 884.4050
Device Class 2

Device Problems
Break 1
Material separation 1
Total Device Problems 2