# DEN170075: ContainOR

- Pathway: De Novo (Direct)
- Applicant: Advanced Surgical Concepts, Ltd.
- Decided: Dec 19, 2017 after 81 days
- Product code: PZQ (General Laparoscopic Power Morcellation Containment System)
- Device class: 2
- Regulation: 21 CFR 878.4825
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. De Novo decisions do not claim a predicate device.

## Indications for use
The ContainOR is a bag containment system intended for use by qualified surgeons for tissue extraction and/or power morcellation during general laparoscopic procedures. The ContainOR is compatible with bipolar or electromechanical laparoscopic power morcellators that are between 15mm and 18mm in shaft outer diameter and 135mm and 180mm in shaft working length and which have an external component that allows for the proper orientation of the laparoscope to perform a contained morcellation.

Source page: https://510kreport.com/device/DEN170075
Methodology: https://510kreport.com/methodology