# K132566: Reprocessed Harmonic Shear

- Pathway: 510(k) (Traditional)
- Applicant: Sterilmed, Inc.
- Decided: Jun 14, 2014 after 303 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: 6 generations back to K801623 (1980). 29 ancestors in all.
No later device cites it as a predicate yet.
0 of 30 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K121550: Harmonic Ace Laparoscopic 5MM Diameter Shears 36CM Length + Adaptive Tissue Technology, Ethicon Endo-Surgery, LLC (2012) Summary page 1.
- K120729: Haronis Ace Laparoscopic 5MM Diameter Shears 36CM Length +Adaptive Tissue Technology Harmonic Ace 5MM Diameter Shears 23, Ethicon Endo-Surgery, LLC (2012) Summary page 1.
- K060245: Harmonic Scalpel Blades and Shears, Ethicon Endo-Surgery, Inc. (2006) Summary page 1.

## Indications for use
The reprocessed harmonic shears are intended to be used for cutting soft tissue and when control of bleeding and minimal thermal injury is desired. The instruments can be used as an adjunct to or a substitute for electrosurgery, lasers, and steel scalpels in general, plastic, pediatric, gynecologic, urologic, thoracic, exposure to orthopedic structures (such as spine and joint space) and other open and endoscopic procedures.

Source page: https://510kreport.com/device/K132566
Methodology: https://510kreport.com/methodology