# K254196: HARMONIC 1100 Shears (HAR1120); HARMONIC 1100 Shears (HAR1136)

- Pathway: 510(k) (Traditional)
- Applicant: Ethicon Endo-Surgery, LLC
- Decided: Sep 17, 2026 after 268 days
- Product code: GEI (Electrosurgical, Cutting & Coagulation & Accessories)
- 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: 11 generations back to K932293 (1994). 68 ancestors in all.
No later device cites it as a predicate yet.
0 of 69 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K200841: Harmonic 1100 Shears, 20cm length, Harmonic 1100 36cm length, Generator G11, Ethicon Endo-Surgery, LLC (2020) Summary page 5.

## Indications for use
The HARMONIC™ 1100 Shears instrument is 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, pediatric, gynecologic, urologic, thoracic, "otorhinolaryngology (ENT)" and sealing and transection of lymphatic vessels. The instruments allow for the coagulation of vessels, up to and including 7 mm in diameter, using the Energy Button with Advanced Hemostasis. The HARMONIC™ 1100 Shears device is indicated for otorhinolaryngology (ENT) procedures in pediatric and adult patients for the ligation and division of vessels, lymphatics and tissue bundles, 2.3-3 mm away from unintended thermally sensitive structures.

Source page: https://510kreport.com/device/K254196
Methodology: https://510kreport.com/methodology