# K232146: Anovo Pedestal

- Pathway: 510(k) (Traditional)
- Applicant: Momentis Surgical, Ltd.
- Decided: Sep 14, 2023 after 57 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.
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)
- DEN190022: Hominis Surgical System, Momentis Surgical, Ltd. (2021) Summary page 4.

## Indications for use
The AnovoTM Pedestal is a reusable optional accessory to the AnovoTM Surgical System intended to assist in supporting and positioning the Robotic Control Unit (RCU). The AnovoTM Pedestal, as well as the AnovoTM Surgical System, is an endoscopic instrument control system that is intended to assist in the accurate control of the Instrument Arms during indicated procedures. The Anovo TM Surgical System is indicated for use in adult patients. It is intended to be used by trained physicians in an operating room environment. The AnovoTM Surgical System is restricted to prescription use only.

Source page: https://510kreport.com/device/K232146
Methodology: https://510kreport.com/methodology