De Novo · Granted
GrantedHominis Surgical System
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
Granted on Feb 26, 2021 as a new device type through De Novo after a 681-day review. 7 later devices descend from it.
- Decided
- Feb 26, 2021
- Review
- 681 days
- Class
- Class II
- Product code
- QNM
- Recalls
- None
7 later devices descend from it, 4 citing it directly.
- This deviceDEN190022 Hominis Surgical SystemMomentis Surgical, Ltd. · 2021
- Descendant · cites it directly · 1 of its ownK243182 Anovo Instrument ARM Curved Scissors; Anovo Instrument ARM Hook…Momentis Surgical, Ltd. · 2025
- Descendant · cites it directly · 1 of its ownK242157 Anovo Surgical System (Model 6Ne)Momentis Surgical, Ltd. · 2024
- Descendant · cites it directly · 1 of its ownK241907 Anovo Surgical System (model 6N)Momentis Surgical, Ltd. · 2024
- Descendant · 2 generations on · 0 of its ownK251761 Anovo Surgical System (Model 6Ne); Anovo Instrument ARM Curved…Momentis Surgical, Ltd. · 2025
- Descendant · 2 generations on · 0 of its ownK250591 Anovo Surgical System (6Ne)Momentis Surgical, Ltd. · 2025
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K243182Anovo Instrument ARM Curved Scissors; Anovo Instrument ARM Hook ElectrodeMomentis Surgical, Ltd. · 2025 · cites it directly1descendant
- K242157Anovo Surgical System (Model 6Ne)Momentis Surgical, Ltd. · 2024 · cites it directly1descendant
- K241907Anovo Surgical System (model 6N)Momentis Surgical, Ltd. · 2024 · cites it directly1descendant
- K251761Anovo Surgical System (Model 6Ne); Anovo Instrument ARM Curved Scissors ; Anovo…Momentis Surgical, Ltd. · 2025 · 2 generations on0descendants
- K250591Anovo Surgical System (6Ne)Momentis Surgical, Ltd. · 2025 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | DEN190022 | Hominis Surgical System | Momentis Surgical, Ltd. | 2021 | — |
| +1 | K243182 | Anovo Instrument ARM Curved Scissors; Anovo Instrument ARM Hook Electrode | Momentis Surgical, Ltd. | 2025 | — |
| +1 | K242157 | Anovo Surgical System (Model 6Ne) | Momentis Surgical, Ltd. | 2024 | — |
| +1 | K241907 | Anovo Surgical System (model 6N) | Momentis Surgical, Ltd. | 2024 | — |
| +2 | K251761 | Anovo Surgical System (Model 6Ne); Anovo Instrument ARM Curved Scissors… | Momentis Surgical, Ltd. | 2025 | — |
| +2 | K250591 | Anovo Surgical System (6Ne) | Momentis Surgical, Ltd. | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 1 | 0 |
| 2024 | 2 | 0 |
| 2025 | 4 | 0 |
Sources: FDA De Novo 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
Does it have a predicate?
De Novo decisions do not claim a predicate device.
What descends from it? (7)
4 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Of its descendants, K243182 (Momentis Surgical, Ltd., 2025) has gone furthest, with 1 descendant of its own.
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. 2021, 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 Hominis Surgical System is an endoscopic instrument control system that is intended to assist in the accurate control of the Hominis Arms during single site, natural orifice laparoscopic-assisted transvaginal benign surgical procedures listed below. The Hominis 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 Hominis Surgical System…
Read the full statement (101 words)
The Hominis Surgical System is an endoscopic instrument control system that is intended to assist in the accurate control of the Hominis Arms during single site, natural orifice laparoscopic-assisted transvaginal benign surgical procedures listed below. The Hominis 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 Hominis 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/DEN190022 · printed Nov 6, 2026
Cite this page
510(k) Report. “DEN190022: Hominis Surgical System.” Lineage record from FDA De Novo data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/DEN190022
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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