# K132512: Harmonic Ace Curved Shears with Scissor Handle, Harmonic Ace Curved Shears with Ergonomic Handle

- Pathway: 510(k) (Special)
- Applicant: Ethicon Endo-Surgery, LLC
- Decided: Oct 24, 2013 after 73 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: 5 generations back to K925699 (1993). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K051036: Harmonic Ace Curved Shears with Pistol Handle and Hand Control, Model ACE23P, ACE36P, Ethicon Endo-Surgery, Inc. (2005) Summary page 2.
- K060245: Harmonic Scalpel Blades and Shears, Ethicon Endo-Surgery, Inc. (2006) Summary page 2.

## Indications for use
The Harmonic Shears are 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 and endoscopic procedures.

Source page: https://510kreport.com/device/K132512
Methodology: https://510kreport.com/methodology