# K062000: Harmonic Wave Coagulating Shears with Scissor Handel and Hand Control, Model WAVE18S; Harmonic Disposable Torque Wrench

- Pathway: 510(k) (Traditional)
- Applicant: Ethicon Endo-Surgery, Inc.
- Decided: Sep 25, 2006 after 70 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
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Harmonic Blades and Shears Expanded Indication: named in the summary without a submission number
- (no number) Harmonic ACE Curved Shears with Scissor Handle and Hand Control: named in the summary without a submission number
- (no number) Harmonic 5mm Curved Shears with Scissor Grip: named in the summary without a submission number

## Most influential descendants
- K093702: Reprocessed Ultrasonic Coagulating Shears (2010), 0 descendants of its own

## Indications for use
The Harmonic WAVE Coagulating Shears with Scissor Handle and Hand Control is indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. The instrument can be used as an adjunct to or substitute for electrosurgery, lasers, and steel scalpels in general, plastic, pediatric, gynecologic, urologic, exposure to orthopedic structures (such as spine and joint space) and other open procedures.

Source page: https://510kreport.com/device/K062000
Methodology: https://510kreport.com/methodology