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. · QNM Mountable Electromechanical Surgical System For Transluminal Approaches
Cleared on Jun 6, 2025 as substantially equivalent to K242157 (Momentis Surgical, Ltd., 2024) after a 99-day review. Its family tree reaches back 2 generations to 2021.
- Decided
- Jun 6, 2025
- Review
- 99 days
- Class
- Class II
- Product code
- QNM
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to DEN190022 (2021). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
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 QNM? 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 QNM device
- #1 K243182 Anovo Instrument ARM Curved Scissors; Anovo…score 11.8 · 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 |
|---|---|---|---|
| * | K242157 | Anovo Surgical System (Model 6Ne)Summary page 5…Electromechanical Surgical System for Name: Transluminal Approaches, Class 2 Product Code: QNM Predicate Device: Anovo Surgical System Model 6Ne K242157 Description: The Anovo Surgical System is an endoscopic instrument control system that is intended to… | 2024 |
| † | K233312 | SOLOASSIST IID / DEXTER ENDOSCOPE ARM (212499); ARTip solo (202426) + ARTip solo voice… | 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?
- The line of descent spans 4 years and passes through 1 company; a new generation was cleared every 3.6 years on median.
- None of the 2 ancestors has a recall.
How does its category compare?
All QNM devicesQNM Mountable Electromechanical Surgical System For Transluminal Approaches: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · QNM
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · QNM
64in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · QNM
No recall names QNM since 2007.
Adverse event reports per year · QNM
1in 2022
MAUDE reports naming product code QNM, 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 | 1 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 1 |
| 2023 | 1 | — | 0 | 0 |
| 2024 | 2 | — | 0 | 0 |
| 2025 | 4 | 64 | 0 | 0 |
| 2026 | 0 | — | 0 | — |
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 single site, natural orifice transvaginal benign laparoscopic-assisted 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…
Read the full statement (101 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 single site, natural orifice transvaginal benign laparoscopic-assisted 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 benign procedures:
* Total benign hysterectomy with salpingo-oophorectomy
* Total benign hysterectomy with salpingectomy
* Total benign hysterectomy
* Salpingectomy
* Oophorectomy
* Adnexectomy
* Ovarian cyst removal
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K250591 · printed Nov 6, 2026
Cite this page
510(k) Report. “K250591: 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/K250591
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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