# K111794: Reprocessed Harmonic Scalpel

- Pathway: 510(k) (Traditional)
- Applicant: Sterilmed, Inc.
- Decided: Jan 11, 2012 after 198 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: 1 generation back to K063192 (2007). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 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.

## Indications for use
The Reprocessed Harmonic FOCUSTM Scalpels (hereinafter harmonic scalpel) is indicated to be used for cutting soft tissue and providing hemostasis when control of bleeding and minimal thermal injury is desired. The instrument can be used as an adjunct to or a substitute for electrosurgery, lasers, and steel scalpels in abdominal, pediatric, gynecologic, exposure to orthopedic structures (such as spine and joint space) and other open procedures.

Source page: https://510kreport.com/device/K111794
Methodology: https://510kreport.com/methodology