510(k) · Cleared
ClearedAnovo Pedestal
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 Sep 14, 2023 as substantially equivalent to DEN190022 (Momentis Surgical, Ltd., 2021) after a 57-day review. Its family tree reaches back 1 generation to 2021.
- Decided
- Sep 14, 2023
- Review
- 57 days
- Class
- Class II
- Product code
- QNM
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to DEN190022 (2021). No later device cites it as a predicate yet.
- Root · 1 generation backDEN190022 Hominis Surgical SystemMomentis Surgical, Ltd. · 2021
- This deviceK232146 Anovo PedestalMomentis Surgical, Ltd. · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | DEN190022 | Hominis Surgical System | Momentis Surgical, Ltd. | 2021 | — |
| 0 (this device) | K232146 | Anovo Pedestal | Momentis Surgical, Ltd. | 2023 | — |
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 |
|---|---|---|---|
| * | DEN190022 | Hominis Surgical SystemSummary page 4…Pedestal Regulatory Class: Class II Product Code: QNM Predicate Devices AnovoTM RCUSS (Robotic Control Unit Support System) by Momentis Surgical Ltd., cleared under DEN190022. Device Description The AnovoTM Pedestal is an optional accessory for the AnovoTM Surgical System. The AnovoTM Pedestal is in… | 2021 |
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.
- 3 other devices also cite its predicate DEN190022.
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. 2023, 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 AnovoTM Pedestal is a reusable optional accessory to the AnovoTM Surgical System intended to assist in supporting and positioning the Robotic Control Unit (RCU).
The AnovoTM Pedestal, as well as the AnovoTM Surgical System, is an endoscopic instrument control system that is intended to assist in the accurate control of the Instrument Arms during indicated procedures. The Anovo TM Surgical System is indicated for use in adult patients. It is intended to be used by trained physicians in an operating room environment. The AnovoTM Surgical System is restricted to prescription use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K232146 · printed Nov 6, 2026
Cite this page
510(k) Report. “K232146: Anovo Pedestal.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K232146
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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