# K161086: Reprocessed Harmonic Shears with Adaptive Tissue Technology (36 cm), Reprocessed Harmonic Shears with Adaptive Tissue Technology (23cm)

- Pathway: 510(k) (Traditional)
- Applicant: Sterilmed, Inc.
- Decided: Sep 20, 2016 after 155 days
- Product code: NUJ (Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed)
- Device class: 2
- Regulation: 21 CFR 878.4400
- 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 5.

## Indications for use
The Reprocessed Harmonic Shears with 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, thoracic, exposure to orthopedic structures (such as spine and joint space) and other open and endoscopic procedures.

Source page: https://510kreport.com/device/K161086
Methodology: https://510kreport.com/methodology