510(k) · Cleared
ClearedDexter 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
Cleared on May 27, 2025 as substantially equivalent to DEN230084 (Distalmotion SA, 2024) after a 102-day review. Its family tree reaches back 1 generation to 2024.
- Decided
- May 27, 2025
- Review
- 102 days
- Class
- Class II
- Product code
- SDD
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to DEN230084 (2024). No later device cites it as a predicate yet.
- Root · 1 generation backDEN230084 Dexter L6 SystemDistalmotion SA · 2024
- This deviceK250435 Dexter L6 SystemDistalmotion SA · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | DEN230084 | Dexter L6 System | Distalmotion SA | 2024 | — |
| 0 (this device) | K250435 | Dexter L6 System | Distalmotion SA | 2025 | — |
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 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
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 |
|---|---|---|---|
| * | DEN230084 | Dexter L6 SystemSummary page 5…ntrol interface Regulatory Class: Class II Product Code: SDD Review Panel: General & Plastic Surgery Predicate Devices: Dexter L6 System (DEN230084) Device Description: The Dexter L6 System is designed to enable complex surgery using a minimally invasive approach. It is co… | 2024 |
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?
- Its one ancestor has no recall.
- 1 other device also cites its predicate DEN230084.
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. 2025, 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, suturing, dissecting, coagulating and cutting, with or without high frequency functionality. The Distalmotion Dexter L6 System is intended for use in laparoscopic inguinal hernia repair and cholecystectomy. The system is indicated for adult use, defined as 22 years old and older. It is intended for use by trained laparoscopic or robotic surgeons in an operating room environment in accordance with the representative and specific procedures set forth in the Instructions for Use.
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/K250435 · printed Nov 6, 2026
Cite this page
510(k) Report. “K250435: Dexter L6 System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K250435
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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