# K254192: Senhance Ultrasonic System

- Pathway: 510(k) (Traditional)
- Applicant: Asensus Surgical
- Decided: May 12, 2026 after 140 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: 2 generations back to K060245 (2006). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K120729: Haronis Ace Laparoscopic 5MM Diameter Shears 36CM Length +Adaptive Tissue Technology Harmonic Ace 5MM Diameter Shears 23, Ethicon Endo-Surgery, LLC (2012) Summary page 5.

## 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 instruments are indicated for the sealing of vessels up to and including 5 mm in diameter. The Senhance Ultrasonic System and accessories are indicated for use with the Senhance Surgical System.

Source page: https://510kreport.com/device/K254192
Methodology: https://510kreport.com/methodology