FDA product code PMU

Containment System, Laparoscopic Power Morcellation, With Instrument Port

Obstetrics/Gynecology·Class 2·21 CFR 884.4050
US regulatory classifications
US Product Code (FDA)
PMU
View Product Code Classification →
US Risk Class (FDA)
Class 2
US Regulation (CFR)
21 CFR 884.4050
View CFR Regulation →
Medical specialty
Obstetrics/Gynecology
Device characteristics
GMP exempt
No
Implantable
No
Life-sustaining
No
Third party review
Not Eligible
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.

Search keywords
About this record

Containment System, Laparoscopic Power Morcellation, With Instrument Port is a medical device type in the Obstetrics/Gynecology specialty. This page includes real-world medical device registration data worldwide for this device type, with registrations from US FDA, Brazil ANVISA, and other global markets.

View regulatory classifications, recent 510(k) clearances, active device registrations, and similar products registered globally under this device category. Pure Global AI's free directory provides comprehensive worldwide registration intelligence across 7,000+ medical device types and 21 specialties.