# K210567: Ultrasonic Surgical System

- Pathway: 510(k) (Traditional)
- Applicant: Miconvey Technologies Co., Ltd.
- Decided: Sep 30, 2022 after 581 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: 4 generations back to K925699 (1993). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K002906: Ultracision Harmonic Scalpel System, Models GEN01, GEN02, GEN03, HP052, HP053, HSA07, Ethicon Endo-Surgery, Inc. (2000) Summary page 5.
- K042777: Harmonic Ace Curved Shears with Hand Control, Model ACE23P, ACE36P, Ethicon Endo-Surgery, Inc. (2004) Summary page 5.

## Indications for use
The K500 Ultrasonic Surgical System is indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. The scalpel can be used as an adjunct or substitute for electrosurgery, laser and steel scalpels.

Source page: https://510kreport.com/device/K210567
Methodology: https://510kreport.com/methodology