# K063192: Harmonic Focus Curved Shears and Torque Wrench, Harmonic Blue Hand Piece and Test Tip

- Pathway: 510(k) (Traditional)
- Applicant: Ethicon Endo-Surgery, LLC
- Decided: Jan 30, 2007 after 102 days
- Product code: LFL (Instrument, Ultrasonic Surgical)
- Device class: U
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
22 later devices descend from it; 5 cite it directly.
0 of 23 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 Scalpel Shears and Hand Piece: 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) Ultracision Curved LCS/CS Shears: named in the summary without a submission number
- (no number) HARMONIC Scalpel Hand Piece: named in the summary without a submission number

## Most influential descendants
- K100597: Harmonic Focus Shears (2010), 18 descendants of its own
- 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

## Recalls of this device
- Mar 16, 2012 · Not classified · Z-1673-2012: Ethicon Endo-Surgery initiated a voluntary recall due to some lot numbers of the HARMONIC Hand Piece (HP054) and the HARMONIC Blue Hand Piece (HPBLUE), which impacts their compatibility with the HARMO

## 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, plastic, pediatric, gynecologic, urologic, exposure to orthopedic structures (such as spine and joint space) and other open procedures. The HARMONIC Blue Hand Piece, when used in conjunction with the HARMONIC Scalpel Instrument, is 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.

Source page: https://510kreport.com/device/K063192
Methodology: https://510kreport.com/methodology