510(k) · Cleared
Recalled · Class II · 2026Versius Surgical System (Versius Plus)
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
Cleared on Dec 16, 2025 as substantially equivalent to DEN230078 (Cmr Surgical Limited, 2024) after a 162-day review. Its family tree reaches back 1 generation to 2024. It has been recalled once.
- Decided
- Dec 16, 2025
- Review
- 162 days
- Class
- Class II
- Product code
- SCV
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 1 generation to DEN230078 (2024). No later device cites it as a predicate yet.
- Root · 1 generation backDEN230078 Versius Surgical SystemCmr Surgical Limited · 2024
- This deviceK252111 Versius Surgical System (Versius Plus)Cmr Surgical Limited · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | DEN230078 | Versius Surgical System | Cmr Surgical Limited | 2024 | — |
| 0 (this device) | K252111 | Versius Surgical System (Versius Plus) | Cmr Surgical Limited | 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 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
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 |
|---|---|---|---|
| * | DEN230078 | Versius Surgical SystemSummary page 5…al 510(k) Classification Panel: General & Plastic Surgery III. PREDICATE DEVICE INFORMATION Predicate Device: Versius Surgical System (DEN230078) Reference Device: System Green (K212808), manufacturer: Richard Wolf GmbH… | 2024 |
| † | K212808 | Logic Hd camera head green, System green | 2022 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 9, 2026 | Class II | Z-2717-2026 | Software design (manufacturing process) | Secure Boot was mistakenly not enabled at manufacturing time, which presents a potential cybersecurity risk. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
- 2 other devices also cite its predicate DEN230078.
How does its category compare?
All SCV devicesSCV Modular Electromechanical Surgical System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, 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/K252111 · printed Nov 6, 2026
Cite this page
510(k) Report. “K252111: Versius Surgical System (Versius Plus).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K252111
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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