SIM

Gynecologic Power Morcellator And Containment System

Product code

SIM

Device name

Gynecologic Power Morcellator And Containment System

Device class

Class 2

21 CFR

21 CFR 884.4075

Medical specialty

Obstetrics/Gynecology

Marketing pathway

510(K)

510(k) clearances (last 3 years)

1

Summaries archived here

0 (direct download)

510(k) clearances (all years, FDA)

1 (all years; only the last 3 years are listed here)

FDA classification definition

A gynecologic power morcellator and containment system is a prescription device consisting of an integrated power morcellator and a containment method that are intended to contain, reduce and remove gynecologic tissue that is not suspected to contain malignancy during minimally invasive surgery.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

510(k) clearances, last 3 years (1)

Last three years. Most recent: 2026-07-02.