# K202166: Senhance Surgical System

- Pathway: 510(k) (Traditional)
- Applicant: Transenterix, Inc.
- Decided: Mar 2, 2021 after 211 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: 17 generations back to K930667 (1994). 51 ancestors in all.
5 later devices descend from it; 2 cite it directly.
1 of 57 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K200049: Senhance Surgical System, Transenterix, Inc. (2020) Summary page 5.

## Most influential descendants
- K212054: Senhance Surgical System (2021), 3 descendants of its own
- K220889: Senhance Surgical System (2022), 2 descendants of its own
- K223095: Senhance Surgical System (2023), 1 descendant of its own
- K233866: Senhance Surgical System (2024), 0 descendants of its own
- K211325: Senhance Surgical System (2021), 0 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 general laparoscopic surgical procedures and laparoscopic gynecological surgery. 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/K202166
Methodology: https://510kreport.com/methodology