# K223095: Senhance Surgical System

- Pathway: 510(k) (Traditional)
- Applicant: Asensus Surgical, Inc.
- Decided: Mar 16, 2023 after 167 days
- Product code: NAY (System, Surgical, Computer Controlled Instrument)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: 1 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 20 generations back to K930667 (1994). 66 ancestors in all.
1 later device descends from it; 1 cites it directly.
1 of 68 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K220889: Senhance Surgical System, Asensus Surgical, Inc. (2022) Summary page 4.
- K171699: da Vinci Xi Surgical System, da Vinci Si Surgical System, da Vinci X Surgical System, Intuitive Surgical, Inc. (2017) Summary page 4.

## Most influential descendants
- K233866: Senhance Surgical System (2024), 0 descendants of its own

## Recalls of this device
- Sep 15, 2023 · Class I · Z-0170-2024: Asensus Surgical has identified a malfunction that has occurred and may recur on the Senhance Surgical System. This issue presented itself as uncontrolled arm motion of the Laparoscope Instrument Actu

## Indications for use
The Senhance Surgical System is intended to assist in the accurate control of laparoscopic instruments for visualization and endoscopic manipulation of tissue including grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery, suturing, mobilization, and retraction. The Senhance Surgical System is intended for use in general laparoscopic surgical procedures and laparoscopic gynecological surgery. The system is indicated for adult and pediatric use. It is intended for use by trained physicians in an operating room environment in accordance with the instructions for use. Use of the device is limited to patients two (2) years of age and older and a weight equal to or above 10kg, who are suitable to be subjected to a conventional endoscopic technique.

Source page: https://510kreport.com/device/K223095
Methodology: https://510kreport.com/methodology