# K212614: Ultrasonic Scalpel System

- Pathway: 510(k) (Traditional)
- Applicant: Surgnova Healthcare Technologies (Zhejiang) Co., Ltd.
- Decided: Jul 18, 2022 after 334 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: 9 generations back to K932293 (1994). 62 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 64 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K141122: Harmonic Scallop Blade, Generator G11, Ethicon Endo-Surgery, LLC (2014) Summary page 4.
- K132612: Harmonic Ace+ Shears 23 CM Length with Advanced Hemostasis, Harmonic Ace + Laparoscopic Shears 36 CM Length with Advance, Ethicon Endo-Surgery, LLC (2013) Summary page 4.

## Most influential descendants
- K233036: Ultrasonic Surgical System (2024), 0 descendants of its own

## Indications for use
The Ultrasonic Scalpel 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 5 mm in diameter while using the power level 1. Device have not been shown to be effective for sterilization procedures or tubal coagulation. Do not use these instruments for these procedures.

Source page: https://510kreport.com/device/K212614
Methodology: https://510kreport.com/methodology