De Novo · Granted
GrantedMagnetic Surgical System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Levita Magnetics International Corp · PNL Magnetic Surgical System
Granted on Jun 13, 2016 as a new device type through De Novo after a 489-day review. 6 later devices descend from it.
- Decided
- Jun 13, 2016
- Review
- 489 days
- Class
- Class II
- Product code
- PNL
- Recalls
- None
6 later devices descend from it, 3 citing it directly.
- This deviceDEN150007 Magnetic Surgical SystemLevita Magnetics International Corp · 2016
- Descendant · cites it directly · 5 of its ownK171429 Magnetic Surgical SystemLevita Magnetics International Corp · 2017
- Descendant · cites it directly · 4 of its ownK180894 Magnetic Surgical SystemLevita Magnetics International Corp · 2018
- Descendant · cites it directly · 3 of its ownK190006 Magnetic Surgical SystemLevita Magnetics International Corp · 2019
- Descendant · 2 generations on · 2 of its ownK191762 Magnetic Surgical SystemLevita Magnetics International Corp · 2020
- Descendant · 3 generations on · 1 of its ownK250746 Magnetic Surgical SystemLevita Magnetics International Corp · 2025
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K171429Magnetic Surgical SystemLevita Magnetics International Corp · 2017 · cites it directly5descendants
- K180894Magnetic Surgical SystemLevita Magnetics International Corp · 2018 · cites it directly4descendants
- K190006Magnetic Surgical SystemLevita Magnetics International Corp · 2019 · cites it directly3descendants
- K191762Magnetic Surgical SystemLevita Magnetics International Corp · 2020 · 2 generations on2descendants
- K250746Magnetic Surgical SystemLevita Magnetics International Corp · 2025 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | DEN150007 | Magnetic Surgical System | Levita Magnetics International Corp | 2016 | — |
| +1 | K171429 | Magnetic Surgical System | Levita Magnetics International Corp | 2017 | — |
| +1 | K180894 | Magnetic Surgical System | Levita Magnetics International Corp | 2018 | — |
| +1 | K190006 | Magnetic Surgical System | Levita Magnetics International Corp | 2019 | — |
| +2 | K191762 | Magnetic Surgical System | Levita Magnetics International Corp | 2020 | — |
| +3 | K250746 | Magnetic Surgical System | Levita Magnetics International Corp | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2025 | 2 | 0 |
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 PNL? 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 PNL device
- #1 K250746 Magnetic Surgical Systemscore 13.7 · 5 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
Does it have a predicate?
De Novo decisions do not claim a predicate device.
What descends from it? (6)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Of its descendants, K171429 (Levita Magnetics International Corp, 2017) has gone furthest, with 5 descendants of its own.
How does its category compare?
All PNL devicesPNL Magnetic Surgical System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.
FDA decisions per year · PNL
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · PNL
Too few PNL 510(k)s in any year since 2007 to give a median.
Recalls per year · PNL
No recall names PNL since 2007.
Adverse event reports per year · PNL
No MAUDE report names PNL 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 | 1 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 1 | — | 0 | 0 |
| 2019 | 1 | — | 0 | 0 |
| 2020 | 1 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 1 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 2 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
to grasp and retract the body and the fundus of the gallbladder in laparoscopic cholecystectomy procedures to facilitate access and visualization of the surgical site. The device is indicated for use in patients within a BMI range of 20 to 34 kg/m2.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/DEN150007 · printed Nov 6, 2026
Cite this page
510(k) Report. “DEN150007: Magnetic Surgical System.” Lineage record from FDA De Novo data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/DEN150007
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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