# DEN190022: Hominis Surgical System

- Pathway: De Novo (Direct)
- Applicant: Momentis Surgical, Ltd.
- Decided: Feb 26, 2021 after 681 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
No predicates in its family tree.
7 later devices descend from it; 4 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. De Novo decisions do not claim a predicate device.

## Most influential descendants
- K243182: Anovo Instrument ARM Curved Scissors; Anovo Instrument ARM Hook Electrode (2025), 1 descendant of its own
- K242157: Anovo Surgical System (Model 6Ne) (2024), 1 descendant of its own
- K241907: Anovo Surgical System  (model 6N) (2024), 1 descendant of its own
- K251761: Anovo Surgical System (Model 6Ne); Anovo Instrument ARM Curved Scissors ; Anovo Instrument ARM Hook Electrode (2025), 0 descendants of its own
- K250591: Anovo Surgical System  (6Ne) (2025), 0 descendants of its own

## Indications for use
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

Source page: https://510kreport.com/device/DEN190022
Methodology: https://510kreport.com/methodology