# K260804: Anovo Surgical System (6Ne)

- Pathway: 510(k) (Traditional)
- Applicant: Momentis Surgical, Ltd.
- Decided: Jul 22, 2026 after 132 days
- Product code: SCV (Modular Electromechanical Surgical System)
- Device class: 2
- Regulation: 21 CFR 878.4964
- 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 DEN230078 (2024). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- DEN230078: Versius Surgical System, Cmr Surgical Limited (2024) Summary page 5.

## 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 laparoscopic-assisted benign 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 single-site, natural orifice, transvaginal benign procedures: • Total benign hysterectomy with salpingo-oophorectomy • Total benign hysterectomy with salpingectomy • Total benign hysterectomy • Salpingectomy • Oophorectomy • Adnexectomy • Ovarian cyst removal Single-site and multi-port transabdominal benign procedures: • Ventral hernia

Source page: https://510kreport.com/device/K260804
Methodology: https://510kreport.com/methodology