De Novo · Granted
GrantedVersius Surgical System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cmr Surgical Limited · SCV Modular Electromechanical Surgical System
Granted on Oct 11, 2024 as a new device type through De Novo after a 325-day review. 3 later devices descend from it.
- Decided
- Oct 11, 2024
- Review
- 325 days
- Class
- Class II
- Product code
- SCV
- Recalls
- None
3 later devices descend from it, 3 citing it directly.
- This deviceDEN230078 Versius Surgical SystemCmr Surgical Limited · 2024
- Descendant · cites it directly · 0 of its ownK260804 Anovo Surgical System (6Ne)Momentis Surgical, Ltd. · 2026
- Descendant · cites it directly · 0 of its ownK252111 Versius Surgical System (Versius Plus)Cmr Surgical Limited · 2025 · Recalled
- Descendant · cites it directly · 0 of its ownK250725 Hugo™ RAS SystemCovidien, LLC · 2025
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | DEN230078 | Versius Surgical System | Cmr Surgical Limited | 2024 | — |
| +1 | K260804 | Anovo Surgical System (6Ne) | Momentis Surgical, Ltd. | 2026 | — |
| +1 | K252111 | Versius Surgical System (Versius Plus) | Cmr Surgical Limited | 2025 | 1 |
| +1 | K250725 | Hugo™ RAS System | Covidien, LLC | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 2 | 0 |
| 2026 | 1 | 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 SCV? 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 SCV device
- #1 K260804 Anovo Surgical System (6Ne)score 11.7 · 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? (3)
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, K260804 (Momentis Surgical, Ltd., 2026) has gone furthest, with 0 descendants of its own.
How does its category compare?
All SCV devicesSCV Modular Electromechanical Surgical System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, this device’s year, is highlighted.
FDA decisions per year · SCV
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · SCV
Too few SCV 510(k)s in any year since 2007 to give a median.
Recalls per year · SCV
1so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · SCV
84in 2025
MAUDE reports naming product code SCV, 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 | 84 |
| 2026 | 2 | — | 1 | — |
What is it indicated for?
The Versius Surgical System is a robotically assisted surgical device that is intended to assist in the precise and accurate control of Versius Surgical endoscopic instruments including rigid endoscopes, blunt and sharp endoscopic dissectors, scissors, forceps/pick-ups, needle holders, electrosurgery, and accessories for endoscopic manipulation of tissue, including grasping, cutting, blunt and sharp dissection, approximation, ligation, electrosurgery and suturing.
The Versius Surgical System is indicated for adult patients 22 years of age and older, eligible for soft tissue minimal access surgery, for cholecystectomy.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/DEN230078 · printed Nov 6, 2026
Cite this page
510(k) Report. “DEN230078: Versius 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/DEN230078
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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