De Novo · Granted
GrantedContainOR
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Advanced Surgical Concepts, Ltd. · PZQ General Laparoscopic Power Morcellation Containment System
Granted on Dec 19, 2017 as a new device type through De Novo after an 81-day review.
- Decided
- Dec 19, 2017
- Review
- 81 days
- Class
- Class II
- Product code
- PZQ
- Recalls
- None
De Novo grants create a new device type without a predicate, so this family tree starts here.
Sources: FDA De Novo database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in PZQ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
Does it have a predicate?
De Novo decisions do not claim a predicate device.
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
How does its category compare?
All PZQ devicesPZQ General Laparoscopic Power Morcellation Containment System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.
FDA decisions per year · PZQ
1in 2017
2026 to Oct 25, outlined.
Median 510(k) review, days · PZQ
Too few PZQ 510(k)s in any year since 2007 to give a median.
Recalls per year · PZQ
No recall names PZQ since 2007.
Adverse event reports per year · PZQ
No MAUDE report names PZQ since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/DEN170075 · printed Nov 6, 2026
Cite this page
510(k) Report. “DEN170075: ContainOR.” Lineage record from FDA De Novo data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/DEN170075
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026