# K133314: Harmonic Focus Shears + Adaptive Tissue Technology

- Pathway: 510(k) (Traditional)
- Applicant: Ethicon Endo-Surgery, LLC
- Decided: Dec 3, 2013 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: 13 generations back to K936109 (1994). 83 ancestors in all.
9 later devices descend from it; 5 cite it directly.
0 of 93 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K100597: Harmonic Focus Shears, Ethicon Endo-Surgery, LLC (2010)

## Most influential descendants
- K153371: Sonicision Cordless Ultrasonic Dissection Device (2016), 4 descendants of its own
- K180149: Sonicision Reusable Generator, Sonicision Reusable Battery Pack, Sonicision Curved Jaw Dissectors (multiple lengths), Sonicision Battery Charger, Sonicision Battery Insertion Guide (2018), 1 descendant of its own
- K212301: Sonicision 7 Curved Jaw Cordless Ultrasonic Dissection Device (2021), 0 descendants of its own
- K200427: Sonicision Cordless Ultrasonic Dissector (2020), 0 descendants of its own
- K190610: Reprocessed HARMONIC FOCUS Shears + Adaptive Tissue Technology (2019), 0 descendants of its own

## Indications for use
The HARMONIC FOCUS' Shears + Adaptive Tissue Technology 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, 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/K133314
Methodology: https://510kreport.com/methodology