Containment System, Laparoscopic Power Morcellation, With Instrument Port
The Containment System, Laparoscopic Power Morcellation, With Instrument Port (product code PMU) is a Class 2 obstetrics and gynecology device used as a multiple instrument port and tissue containment system during minimally invasive gynecologic laparoscopic surgery to enable isolation and containment of tissue considered benign during power morcellation, regulated under 884.4050. It requires 510(k) clearance and is compatible with specific bipolar or electromechanical laparoscopic power morcellators within defined diameter and length specifications. The device is not an implant and is not life-sustaining.
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Basic Information
- Product Code
- PMU
- Device Class
- FDA class 2
- Regulation Number
- 884.4050
- Medical Specialty
- Obstetrics/Gynecology
- Review Panel
- OB
- Submission Type
- 1
Device Characteristics
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.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 4 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K250212 | LapBox Power Tissue Containment System | Apr 15, 2025 | Substantially Equivalent | Ark Surgical |
| K212659 | More-Cell-System | Nov 10, 2021 | Substantially Equivalent | Agency For Medical Innovations GmbH |
| K192898 | PneumoLiner | Feb 25, 2020 | Substantially Equivalent | Advanced Surgical Concepts |
| DEN150028 | PneumoLiner | Apr 07, 2016 | Unknown | Advanced Surgical Concepts, Ltd. |
FEI Numbers
This FDA classification entry is associated with 7 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 7 registration numbers. Click on an entry to view related FDA registrations.