# K190610: Reprocessed HARMONIC FOCUS Shears + Adaptive Tissue Technology

- Pathway: 510(k) (Traditional)
- Applicant: Sterilmed, Inc.
- Decided: Aug 15, 2019 after 157 days
- Product code: NLQ (Single-Use Reprocessed Ultrasonic Surgical Instruments)
- 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: 14 generations back to K936109 (1994). 84 ancestors in all.
No later device cites it as a predicate yet.
0 of 85 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K133314: Harmonic Focus Shears + Adaptive Tissue Technology, Ethicon Endo-Surgery, LLC (2013) Summary page 6.

## Indications for use
The Reprocessed 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/K190610
Methodology: https://510kreport.com/methodology