# K242157: Anovo Surgical System (Model 6Ne)

- Pathway: 510(k) (Traditional)
- Applicant: Momentis Surgical, Ltd.
- Decided: Oct 21, 2024 after 90 days
- Product code: QNM (Mountable Electromechanical Surgical System For Transluminal Approaches)
- Device class: 2
- Regulation: 21 CFR 878.4961
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to DEN190022 (2021). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- DEN190022: Hominis Surgical System, Momentis Surgical, Ltd. (2021) Summary page 5.

## Most influential descendants
- K250591: Anovo Surgical System  (6Ne) (2025), 0 descendants of its own

## Indications for use
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

Source page: https://510kreport.com/device/K242157
Methodology: https://510kreport.com/methodology