# K191555: HARMONIC HD 1000i Shears, 20 cm length, HARMONIC HD 1000i Shears, 36 cm length

- Pathway: 510(k) (Traditional)
- Applicant: Ethicon Endo-Surgery, LLC
- Decided: Feb 28, 2020 after 261 days
- Product code: LFL (Instrument, Ultrasonic Surgical)
- Device class: U
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K072177 (2007). 7 ancestors in all.
5 later devices descend from it; 1 cites it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K160752: HARMONIC HD 1000i Shears 20 cm Length, HARMONIC HD 1000i Shears 36 cm Length, Ethicon Endo-Suregery, LLC (2016) Summary page 6.

## Most influential descendants
- K200841: Harmonic 1100 Shears, 20cm length, Harmonic 1100 36cm length, Generator G11 (2020), 4 descendants of its own
- K233471: Reprocessed HARMONIC 1100 Shears, 5mm Diameter, 20cm length (HAR1120); Reprocessed HARMONIC 1100 Shears, 5mm Diameter, 36cm length (HAR1136) (2024), 1 descendant of its own
- K254196: HARMONIC 1100 Shears (HAR1120); HARMONIC 1100 Shears (HAR1136) (2026), 0 descendants of its own
- K243067: The ETHICON™ Total Energy System (2025), 0 descendants of its own
- K241606: Reprocessed HARMONIC 1100 Shears, 5mm Diameter, 20cm Length (HAR1120); Reprocessed HARMONIC 1100 Shears, 5mm Diameter, 36cm Length (HAR1136) (2024), 0 descendants of its own

## Recalls of this device
- Jul 20, 2021 · Class II · Z-2355-2021: An internal component may be cracked and become lodged behind the energy button potentially resulting in continuous activation of the device, may result in burns
- Jul 20, 2021 · Class II · Z-2356-2021: An internal component may be cracked and become lodged behind the energy button potentially resulting in continuous activation of the device, may result in burns

## Indications for use
The Harmonic HD 1000i Shears instrument is 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), sealing and transection of lymphatic vessels, and other open and endoscopic procedures. The instruments allow for the coagulation of vessels up to and including 7 mm in diameter, using the Energy button with Advanced Hemostasis.

Source page: https://510kreport.com/device/K191555
Methodology: https://510kreport.com/methodology