# K180163: TransEnterix Senhance Surgical System

- Pathway: 510(k) (Traditional)
- Applicant: Transenterix, Inc.
- Decided: May 25, 2018 after 126 days
- Product code: NAY (System, Surgical, Computer Controlled Instrument)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 12 generations back to K930667 (1994). 46 ancestors in all.
11 later devices descend from it; 1 cites it directly.
1 of 58 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K171120: Senhance Surgical Robotic System, Transenterix, Inc. (2017) Summary page 4.

## Most influential descendants
- K181517: Senhance Surgical System (2018), 10 descendants of its own
- K191482: Senhance Surgical System (2019), 8 descendants of its own
- K192877: Senhance Surgical System (2019), 7 descendants of its own
- K200049: Senhance Surgical System (2020), 6 descendants of its own
- K202166: Senhance Surgical System (2021), 5 descendants of its own

## 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 laparoscopic gynecological surgery, colorectal surgery, cholecystectomy, and inguinal hernia repair. The system is indicated for adult use. It is intended for use by trained physicians in an operating room environment in accordance with the Instructions for Use.

Source page: https://510kreport.com/device/K180163
Methodology: https://510kreport.com/methodology