# K042777: Harmonic Ace Curved Shears with Hand Control, Model ACE23P, ACE36P

- Pathway: 510(k) (Traditional)
- Applicant: Ethicon Endo-Surgery, Inc.
- Decided: Dec 1, 2004 after 56 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: 3 generations back to K925699 (1993). 5 ancestors in all.
39 later devices descend from it; 4 cite it directly.
0 of 45 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K993054: Ultracision Harmonic Scalpel Coagulating Shears, Models LCS-C5, LCS-C1, CS-23C, CS-231, CS-14C, CS-141, Ethicon Endo-Surgery, Inc. (1999) Summary page 1.
- K002906: Ultracision Harmonic Scalpel System, Models GEN01, GEN02, GEN03, HP052, HP053, HSA07, Ethicon Endo-Surgery, Inc. (2000) Summary page 1.

## Most influential descendants
- K093217: 5 MM Harmonic Ace Instrument (Used with DA Vinci IS1200 & IS2000/IS3000 System) (2010), 16 descendants of its own
- K112584: 5MM/8MM Harmonic Ace (TM) Curved Shears, Disposable Harmonic Ace (TM) Insert, Disposable Harmonic (TM) Curved Shears Insert (2011), 15 descendants of its own
- K051036: Harmonic Ace Curved Shears with Pistol Handle and Hand Control, Model ACE23P, ACE36P (2005), 14 descendants of its own
- K111202: Surgical Tissue Management System (2012), 11 descendants of its own
- K143132: IS4000 8mm Harmonic ACE Curved Shears (2015), 9 descendants of its own

## Indications for use
The Harmonic ACETM Curved Shears with 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, pediatric, gynecologic, urologic and other open and endoscopic procedures.

Source page: https://510kreport.com/device/K042777
Methodology: https://510kreport.com/methodology