510(k) · Cleared
ClearedAnovo Surgical System (6Ne)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Momentis Surgical, Ltd. · SCV Modular Electromechanical Surgical System
Cleared on Jul 22, 2026 as substantially equivalent to DEN230078 (Cmr Surgical Limited, 2024) after a 132-day review. Its family tree reaches back 1 generation to 2024.
- Decided
- Jul 22, 2026
- Review
- 132 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 deviceK260804 Anovo Surgical System (6Ne)Momentis Surgical, Ltd. · 2026
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) | K260804 | Anovo Surgical System (6Ne) | Momentis Surgical, Ltd. | 2026 | — |
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 K250725 Hugo™ RAS Systemscore 10.4 · 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…tion: 21 CFR 878.4964 Modular electromechanical surgical system, Product Code SCV, Class 2 Predicate: Versius Surgical System (DEN230078) Reference Device: Anovo Surgical System model 6Ne (K251761) Description: The Anovo Surgical System is a robotic… | 2024 |
| † | K251761 | Anovo Surgical System (Model 6Ne); Anovo Instrument ARM Curved Scissors ; Anovo… | 2025 |
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. 2026, 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 Anovo Surgical System is an endoscopic instrument control system that is intended to assist in the accurate control of the Instrument ARMS during laparoscopic-assisted benign surgical procedures listed below. The Anovo Surgical System is indicated for use in adult patients. It is intended to be used by trained physicians in an operating room environment. The representative uses of the Anovo Surgical System are indicated for the following single-site…
Read the full statement (109 words)
The Anovo Surgical System is an endoscopic instrument control system that is intended to assist in the accurate control of the Instrument ARMS during laparoscopic-assisted benign surgical procedures listed below.
The Anovo Surgical System is indicated for use in adult patients. It is intended to be used by trained physicians in an operating room environment.
The representative uses of the Anovo Surgical System are indicated for the following single-site, natural orifice, transvaginal benign procedures:
• Total benign hysterectomy with salpingo-oophorectomy
• Total benign hysterectomy with salpingectomy
• Total benign hysterectomy
• Salpingectomy
• Oophorectomy
• Adnexectomy
• Ovarian cyst removal
Single-site and multi-port transabdominal benign procedures:
• Ventral hernia
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K260804 · printed Nov 6, 2026
Cite this page
510(k) Report. “K260804: Anovo Surgical System (6Ne).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K260804
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026