# K002906: Ultracision Harmonic Scalpel System, Models GEN01, GEN02, GEN03, HP052, HP053, HSA07

- Pathway: 510(k) (Traditional)
- Applicant: Ethicon Endo-Surgery, Inc.
- Decided: Dec 15, 2000 after 88 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.
69 later devices descend from it; 10 cite it directly.
0 of 70 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K042777: Harmonic Ace Curved Shears with Hand Control, Model ACE23P, ACE36P (2004), 39 descendants of its own
- 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
- K050550: Gyrus General Purpose Electrosurgical Generator (2005), 14 descendants of its own
- K051036: Harmonic Ace Curved Shears with Pistol Handle and Hand Control, Model ACE23P, ACE36P (2005), 14 descendants of its own

Source page: https://510kreport.com/device/K002906
Methodology: https://510kreport.com/methodology