# K182421: Senhance Ultrasonic System

- Pathway: 510(k) (Traditional)
- Applicant: Transenterix, Inc.
- Decided: Jan 11, 2019 after 128 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: 8 generations back to K930667 (1994). 24 ancestors in all.
No later device cites it as a predicate yet.
0 of 25 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K112584: 5MM/8MM Harmonic Ace (TM) Curved Shears, Disposable Harmonic Ace (TM) Insert, Disposable Harmonic (TM) Curved Shears Insert, Intuitive Surgical, Inc. (2011) Summary page 1.

## Indications for use
The Senhance Ultrasonic System and accessories are indicated for soft tissue surgical incisions when bleeding control and minimal thermal injury are important. The Senhance Ultrasonic System and accessories are indicated for use with the Senhance Surgical System.

Source page: https://510kreport.com/device/K182421
Methodology: https://510kreport.com/methodology