510(k) K250212

Clearance Details

Decision

SESE (Substantially Equivalent)

Decision Date

April 15, 2025

Date Received

January 24, 2025

Clearance Type

Traditional

Expedited Review

No

Third Party Review

No

Device Classification

Device Name

Containment System, Laparoscopic Power Morcellation, With Instrument Port

Device Class

Class II

Regulation Number

884.4050

Review Panel

OB

Submission Type

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.