510(k) · Cleared
ClearedSurgeon Controlled Arm
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
Cleared on Aug 4, 2023 as substantially equivalent to K171947 (Aktormed GmbH, 2018) after a 240-day review. Its family tree reaches back 5 generations to 1993.
- Decided
- Aug 4, 2023
- Review
- 240 days
- Class
- Class II
- Product code
- PNL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K931783 (1993). No later device cites it as a predicate yet.
- Root · 5 generations backK931783 Aesop (Automated Endoscopic System for Optimal PosComputer Motion, Inc. · 1993
- 4 generations backK960655 Aesop System and AccessoriesComputer Motion, Inc. · 1996
- 3 generations backK963126 Aesop System and AccessoriesComputer Motion, Inc. · 1997
- 2 generations backK972699 Aesop 3000 System and AccessoriesComputer Motion, Inc. · 1997
- 1 generation backK171947 Soloassist IIAktormed GmbH · 2018
- This deviceK223673 Surgeon Controlled ArmLevita Magnetics International Corp · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K931783 | Aesop (Automated Endoscopic System for Optimal Pos | Computer Motion, Inc. | 1993 | — |
| −4 | K960655 | Aesop System and Accessories | Computer Motion, Inc. | 1996 | — |
| −3 | K963126 | Aesop System and Accessories | Computer Motion, Inc. | 1997 | — |
| −2 | K972699 | Aesop 3000 System and Accessories | Computer Motion, Inc. | 1997 | — |
| −1 | K171947 | Soloassist II | Aktormed GmbH | 2018 | — |
| 0 (this device) | K223673 | Surgeon Controlled Arm | Levita Magnetics International Corp | 2023 | — |
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 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
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 |
|---|---|---|---|
| * | K171947 | Soloassist IISummary page 4…Classification Name: Magnetic Surgical Instrument System (21CFR 878.4815) Device Class: II Product Code: PNL (Magnetic Surgical System) Predicate Device: K171947, AKTORmed GmbH SOLOASSIST II Date Prepared: June 30, 2023 Device Description: The Surgeon Controlled Arm for the Levita Magneti… | 2018 |
| † | K191762 | Magnetic Surgical System | 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 30 years and passes through 3 companies; a new generation was cleared every 2.4 years on median.
- None of the 5 ancestors has a recall.
- 1 other device also cites its predicate K171947.
How does its category compare?
All PNL devicesPNL Magnetic Surgical System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, 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?
The Surgeon Controlled Arm is indicated for use to hold and position a rigid laparoscope/endoscope and the Magnetic Controller of the Levita Magnetic Surgical System in minimally invasive interventions where the Levita Magnetic Surgical System is indicated for use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K223673 · printed Nov 4, 2026
Cite this page
510(k) Report. “K223673: Surgeon Controlled Arm.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K223673
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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