# K100597: Harmonic Focus Shears

- Pathway: 510(k) (Traditional)
- Applicant: Ethicon Endo-Surgery, LLC
- Decided: Apr 7, 2010 after 36 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: 12 generations back to K936109 (1994). 82 ancestors in all.
18 later devices descend from it; 3 cite it directly.
0 of 101 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K063192: Harmonic Focus Curved Shears and Torque Wrench, Harmonic Blue Hand Piece and Test Tip, Ethicon Endo-Surgery, LLC (2007) Summary page 1.
- K060245: Harmonic Scalpel Blades and Shears, Ethicon Endo-Surgery, Inc. (2006) Summary page 1.
- K012176: Ultracision Harmonic Scalpel Blades with Protective Sleeve, Models DH105, DH145, SH105, SH145, Ethicon Endo-Surgery, Inc. (2001) Summary page 1.
- K990362: Instrument, Ultrasonic, Scalpel, Ethicon Endo-Surgery, Inc. (1999) Summary page 1.
- K031305: Olympus Ultrasonic Surgical System, Olympus Optical Co., Ltd. (2003) Summary page 1.
- K041868: Valupen,Profile, Conmed Corporation (2004) Summary page 1.
- K070374: Arthrocare Ent Plasma Wand, Arthrocare Corp. (2007) Summary page 1.
- K030108: Arthrocare Ent Coblator Surgery System, Arthrocare Corp. (2003)

## Most influential descendants
- K133314: Harmonic Focus Shears + Adaptive Tissue Technology (2013), 9 descendants of its own
- K151743: THUNDERBEAT Open Fine Jaw (2016), 6 descendants of its own
- K192103: Thunderbeat Open Fine Jaw Type X Hand Instrument (2020), 4 descendants of its own
- K153371: Sonicision Cordless Ultrasonic Dissection Device (2016), 4 descendants of its own
- K211838: Ultrasonic Bipolar Generator USG-410 with accessories (2021), 3 descendants of its own

## Indications for use
The HARMONIC FOCUS Shears are indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. The instruments can be used as an adjunct to or substitute for electrosurgery, lasers, and steel scalpels in general, otorhinolaryngologic (ENT), plastic, pediatric, gynecologic, urologic, exposure to orthopedic structures (such as spine and joint space), and other open procedures.

Source page: https://510kreport.com/device/K100597
Methodology: https://510kreport.com/methodology