# K233036: Ultrasonic Surgical System

- Pathway: 510(k) (Traditional)
- Applicant: Hunan Handlike Minimally Invasive Surgery Co., Ltd.
- Decided: Jun 18, 2024 after 267 days
- Product code: LFL (Instrument, Ultrasonic Surgical)
- Device class: U
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K932293 (1994). 72 ancestors in all.
No later device cites it as a predicate yet.
0 of 73 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K212614: Ultrasonic Scalpel System, Surgnova Healthcare Technologies (Zhejiang) Co., Ltd. (2022) Summary page 5.
- K151136: Harmonic Hook, Ethicon Endo-Surgery, LLC (2016) Summary page 6.

## Indications for use
The Ultrasonic Surgical System is intended to be used to transect, dissect, and coagulate tissue. The instruments are indicated for use in open and endoscopic general surgical procedures where bleeding control and minimal thermal injury to tissue are desired. The instruments allow for the coagulation of vessels (veins and arteries) up to 3 mm in diameter.

Source page: https://510kreport.com/device/K233036
Methodology: https://510kreport.com/methodology