De Novo · Granted
GrantedDexter L6 System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Distalmotion SA · SDD Electromechanical Surgical System Wherein The Surgeon Annd The User Interface Can Be In The Sterile Field
Granted on Oct 25, 2024 as a new device type through De Novo after a 315-day review. 4 later devices descend from it.
- Decided
- Oct 25, 2024
- Review
- 315 days
- Class
- Class II
- Product code
- SDD
- Recalls
- None
4 later devices descend from it, 2 citing it directly.
- This deviceDEN230084 Dexter L6 SystemDistalmotion SA · 2024
- Descendant · cites it directly · 2 of its ownK251197 Dexter L6 SystemDistalmotion SA · 2025
- Descendant · 2 generations on · 0 of its ownK261398 Dexter L6 SystemDistalmotion SA · 2026
- Descendant · 2 generations on · 0 of its ownK260653 Dexter L6 SystemDistalmotion SA · 2026
- Descendant · cites it directly · 0 of its ownK250435 Dexter L6 SystemDistalmotion SA · 2025
Most influential descendants
Showing 4 of 4 · See all- K251197Dexter L6 SystemDistalmotion SA · 2025 · cites it directly2descendants
- K261398Dexter L6 SystemDistalmotion SA · 2026 · 2 generations on0descendants
- K260653Dexter L6 SystemDistalmotion SA · 2026 · 2 generations on0descendants
- K250435Dexter L6 SystemDistalmotion SA · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | DEN230084 | Dexter L6 System | Distalmotion SA | 2024 | — |
| +1 | K251197 | Dexter L6 System | Distalmotion SA | 2025 | — |
| +2 | K261398 | Dexter L6 System | Distalmotion SA | 2026 | — |
| +2 | K260653 | Dexter L6 System | Distalmotion SA | 2026 | — |
| +1 | K250435 | Dexter L6 System | Distalmotion SA | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 2 | 0 |
| 2026 | 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 SDD? 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 SDD device
- #1 K251197 Dexter L6 Systemscore 16.1 · 1 generation · 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? (4)
2 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, K251197 (Distalmotion SA, 2025) has gone furthest, with 2 descendants of its own.
How does its category compare?
All SDD devicesSDD Electromechanical Surgical System Wherein The Surgeon Annd The User Interface Can Be In The Sterile Field: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, this device’s year, is highlighted.
FDA decisions per year · SDD
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · SDD
Too few SDD 510(k)s in any year since 2007 to give a median.
Recalls per year · SDD
No recall names SDD since 2007.
Adverse event reports per year · SDD
3in 2025
MAUDE reports naming product code SDD, 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 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 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 | 1 | — | 0 | 0 |
| 2025 | 2 | — | 0 | 3 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
The Distalmotion Dexter L6 System is intended to assist in the accurate control of endoscopes as well as endoscopic instruments for endoscopic manipulation of tissue, including grasping, dissecting, coagulating and cutting, with or without high frequency functionality. The Distalmotion Dexter L6 System is intended for use in laparoscopic inguinal hernia repair. The system is indicated for adult uses, as defined as 22 years old and older. It is intended for use by trained laparoscopic surgeons in an operating room environment in accordance with the representative and specific procedures set forth in the Instructions for Use.
The Dexter L6 System is for prescription use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/DEN230084 · printed Nov 6, 2026
Cite this page
510(k) Report. “DEN230084: Dexter L6 System.” Lineage record from FDA De Novo data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/DEN230084
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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