510(k) · Cleared

Cleared

Anovo Instrument ARM Curved Scissors; Anovo Instrument ARM Hook Electrode

K243182510(k) TraditionalCleared Feb 3, 2025126-day reviewClass II21 CFR 878.4961

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Momentis Surgical, Ltd. · QNM Mountable Electromechanical Surgical System For Transluminal Approaches

Cleared on Feb 3, 2025 as substantially equivalent to DEN190022 (Momentis Surgical, Ltd., 2021) after a 126-day review. Its family tree reaches back 1 generation to 2021. 1 later device descends from it.

Decided: Feb 3, 2025
Review: 126 days
Class: Class II
Product code: QNM
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to DEN190022 (2021). 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backDEN190022 Hominis Surgical SystemMomentis Surgical, Ltd. · 2021
This deviceK243182 Anovo Instrument ARM Curved Scissors; Anovo Instrument ARM Hook…Momentis Surgical, Ltd. · 2025
Descendant · cites it directly · 0 of its ownK251056 Anovo Instrument ARM Curved Scissors ; Anovo Instrument ARM Hook…Momentis Surgical, Ltd. · 2025

Most influential descendants

Showing 1 of 1 · See all

K251056Anovo Instrument ARM Curved Scissors ; Anovo Instrument ARM Hook ElectrodeMomentis Surgical, Ltd. · 2025 · cites it directly0descendants

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)	K243182	Anovo Instrument ARM Curved Scissors; Anovo Instrument ARM Hook Electrode	Momentis Surgical, Ltd.	2025	—
+1	K251056	Anovo Instrument ARM Curved Scissors ; Anovo Instrument ARM Hook Electrode	Momentis Surgical, Ltd.	2025	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2025	1	0

FIG. 1 — Lineage of K243182, 2021–2025Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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 K242157 Anovo Surgical System (Model 6Ne)score 11.2 · 1 generation · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

Get a 510(k) 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	Applicant	Decided	Recalls
*	DEN190022	Hominis Surgical System Summary page 5 …ctromechanical Surgical System for Transluminal Approachs Product Code QNM, Class 2 Predicate Device: Anovo™ Instrument ARM Grasper end-effector (DEN190022) Description: The Anovo™ Instrument ARM Curved Scissors and Anovo™ Instrument ARM Hook Electrode are…	Momentis Surgical, Ltd.	2021	—

Also cleared against DEN190022: 3 other devices →

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K251056	Anovo Instrument ARM Curved Scissors ; Anovo Instrument ARM Hook Electrode	Momentis Surgical, Ltd.	2025	0

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.
Of its descendants, K251056 (Momentis Surgical, Ltd., 2025) has gone furthest, with 0 descendants of its own.
3 other devices also cite its predicate DEN190022.

How does its category compare?

All QNM devices

QNM 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

2007high 4 (2025) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · QNM

64in 2025

2007high 64 (2025)2026

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

2007high 1 (2022) · low 0 (2007)2025

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	MAUDE reports
2007	0	—	0
2008	0	—	0
2009	0	—	0
2010	0	—	0
2011	0	—	0
2012	0	—	0
2013	0	—	0
2014	0	—	0
2015	0	—	0
2016	0	—	0
2017	0	—	0
2018	0	—	0
2019	0	—	0
2020	0	—	0
2021	1	—	0
2022	0	—	1
2023	1	—	0
2024	2	—	0
2025	4	64	0
2026	0	—	—

What is it indicated for?

The AnovoTM Instrument ARM Curved Scissors is indicated for use for tissue manipulation including cutting, dissecting, and coagulating and cutting using monopolar energy. The AnovoTM Instrument ARM Hook Electrode is indicated for use for tissue manipulation including dissecting, and coagulating and cutting using monopolar energy. The AnovoTM Instrument ARM Curved Scissors and the AnovoTM Instrument ARM Hook Electrode are intended for use with the…

Read the full statement (169 words)

The AnovoTM Instrument ARM Curved Scissors is indicated for use for tissue manipulation including cutting, dissecting, and coagulating and cutting using monopolar energy.

The AnovoTM Instrument ARM Hook Electrode is indicated for use for tissue manipulation including dissecting, and coagulating and cutting using monopolar energy.

The AnovoTM Instrument ARM Curved Scissors and the AnovoTM Instrument ARM Hook Electrode are intended for use with the AnovoTMr Surgical System.

The AnovoTM 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 laparoscopic-assisted transvaginal benign surgical procedures listed below.

The Anovo T M 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 AnovoTM 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/K243182 · printed Nov 6, 2026

Cite this page

510(k) Report. “K243182: Anovo Instrument ARM Curved Scissors; Anovo Instrument ARM Hook Electrode.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K243182

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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