510(k) · Cleared
ClearedMore-Cell-System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Agency For Medical Innovations GmbH · PMU Containment System, Laparoscopic Power Morcellation, With Instrument Port
Cleared on Nov 10, 2021 as substantially equivalent to K192898 (Advanced Surgical Concepts, 2020) after a 79-day review. Its family tree reaches back 2 generations to 2016.
- Decided
- Nov 10, 2021
- Review
- 79 days
- Class
- Class II
- Product code
- PMU
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to DEN150028 (2016). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
Sources: FDA 510(k) 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 PMU? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new PMU device
- #1 K250212 LapBox Power Tissue Containment Systemscore 9.5 · 2 generations · no Class I recall
- #2 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K192898 | PneumoLinerSummary page 4…er morcellation containment system (21 CFR 884.4050, Product Code PMU, Class II) PREDICATE DEVICE IDENTIFICATION 510(k) Number Predicate Device Name / Manufacturer K192898 PneumoLiner / Advanced Surgical Concepts The predicate device has not been subject to a design-related recall. DEVICE… | 2020 |
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.
What does this lineage say?
- The line of descent spans 5 years and passes through 3 companies; a new generation was cleared every 3.9 years on median.
- 1 of the 2 ancestors has a recall of any class.
- 1 other device also cites its predicate K192898.
How does its category compare?
All PMU devicesPMU Containment System, Laparoscopic Power Morcellation, With Instrument Port: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, this device’s year, is highlighted.
FDA decisions per year · PMU
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · PMU
Too few PMU 510(k)s in any year since 2007 to give a median.
Recalls per year · PMU
1in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · PMU
3in 2023
MAUDE reports naming product code PMU, not matched to any one device; reports are not rates.
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 | 1 | — | 0 | 1 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 2 |
| 2019 | 0 | — | 0 | 3 |
| 2020 | 1 | — | 0 | 1 |
| 2021 | 1 | — | 1 | 2 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 3 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 1 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
More-Cell-System is intended for use as a tissue containment system during minimally invasive gynecologic laparoscopic surgery to enable the isolation and containment of tissue considered benign, resected during multi-site laparoscopic surgery for power morcellation and removal.
When used in women with fibroids, the More-Cell System is for women who are pre-menopausal and under age 50. More-Cell-System is compatible with electromechanical laparoscopic power morcellators that are between 12 mm and 20 mm in shaft outer diameter and between 95 mm and 170 mm in shaft working length.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K212659 · printed Nov 4, 2026
Cite this page
510(k) Report. “K212659: More-Cell-System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K212659
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)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026