510(k) · Cleared
ClearedHugo™ RAS System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Covidien, LLC · SCV Modular Electromechanical Surgical System
Cleared on Dec 3, 2025 as substantially equivalent to DEN230078 (Cmr Surgical Limited, 2024) after a 268-day review. Its family tree reaches back 1 generation to 2024.
- Decided
- Dec 3, 2025
- Review
- 268 days
- Class
- Class II
- Product code
- SCV
- Recalls
- None
- 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 deviceK250725 Hugo™ RAS SystemCovidien, LLC · 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) | K250725 | Hugo™ RAS System | Covidien, LLC | 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 7…Submission Type: Traditional 510(k) 3. Predicate Device Information Manufacturer Name: CMR Surgical Limited DeNovo Approval Number: DEN230078 Trade Name: Versius Surgical System Classification Name: General & Plastic Surgery (21 CFR 878.496… | 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.
- 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 Hugo™ Robotically Assisted Surgery (RAS) System is intended to assist in the accurate control of instruments and accessories including rigid endoscopes, blunt and sharp endoscopic dissectors, scissors, forceps/graspers, needle holders, electrosurgical tools and accessories for endoscopic manipulation of tissue, including grasping, cutting, blunt and sharp dissection, approximation, ligation, electrosurgery, and suturing during minimally invasive…
Read the full statement (95 words)
The Hugo™ Robotically Assisted Surgery (RAS) System is intended to assist in the accurate control of instruments and accessories including rigid endoscopes, blunt and sharp endoscopic dissectors, scissors, forceps/graspers, needle holders, electrosurgical tools and accessories for endoscopic manipulation of tissue, including grasping, cutting, blunt and sharp dissection, approximation, ligation, electrosurgery, and suturing during minimally invasive urologic surgical procedures. The system is indicated for adult use. It is intended to be used by trained physicians in an operating room environment in accordance with the representative surgical procedures set forth in the Hugo™ RAS System Indications Document.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K250725 · printed Nov 5, 2026
Cite this page
510(k) Report. “K250725: Hugo™ RAS System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K250725
Report an extraction error
Are you the manufacturer?
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