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U.S. Department of Health and Human Services

Product Classification

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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 pneumoliner 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.
Physical State A retractor and boot assembly with a tissue pouch/specimen bag
Technical Method A tissue pouch is placed through a multi-instrument port to allow for containment of resected gynecologic tissue. The pouch is insufflated to create a working space for morcellation. A laparoscopic power morcellator and a laparoscope are placed through the port and into the pouch to enable visualization of the morcellation.
Target Area abdomen
Regulation Medical Specialty Obstetrics/Gynecology
Review Panel Obstetrics/Gynecology
Product CodePMU
Premarket Review Office of Device Evaluation (ODE)
Division of Reproductive, Gastro-Renal, and Urological Devices (DRGUD)
Obstetrics and Gynecology Devices Branch (OGDB)
Submission Type 510(k)
Regulation Number 884.4050
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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