# K133672: Reprocessed Harmonic Ace Shears Without Adaptive Tissue Technology

- Pathway: 510(k) (Traditional)
- Applicant: Stryker Sustainability Solutions
- Decided: May 1, 2014 after 153 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: 11 generations back to K942299 (1995). 48 ancestors in all.
No later device cites it as a predicate yet.
0 of 49 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K112072: Atricure Cryo Module System, AtriCure, Inc. (2011) Summary page 1.
- K060245: Harmonic Scalpel Blades and Shears, Ethicon Endo-Surgery, Inc. (2006) Summary page 1.

## Indications for use
Reprocessed HARMONIC ACE® Shears without Adaptive Tissue Technology 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 and endoscopic procedures.

Source page: https://510kreport.com/device/K133672
Methodology: https://510kreport.com/methodology