PMU — Containment System, Laparoscopic Power Morcellation, With Instrument Port Class II
FDA product code PMU covers "Containment System, Laparoscopic Power Morcellation, With Instrument Port", a Class II medical device regulated under 21 CFR 884.4050. Submissions are reviewed by the Obstetrics/Gynecology panel. At least 4 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- PMU
- Device Class
- Class II
- Regulation Number
- 884.4050
- Submission Type
- Review Panel
- OB
- Medical Specialty
- Obstetrics/Gynecology
- Implant
- No
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K250212 | ark surgical | LapBox Power Tissue Containment System | April 15, 2025 |
| K212659 | agency for medical innovations | More-Cell-System | November 10, 2021 |
| K192898 | advanced surgical concepts | PneumoLiner | February 25, 2020 |
| DEN150028 | advanced surgical concepts | PneumoLiner | April 7, 2016 |