# K132612: Harmonic Ace+ Shears 23 CM Length with Advanced Hemostasis, Harmonic Ace + Laparoscopic Shears 36 CM Length with Advance

- Pathway: 510(k) (Traditional)
- Applicant: Ethicon Endo-Surgery, LLC
- Decided: Oct 17, 2013 after 57 days
- Product code: LFL (Instrument, Ultrasonic Surgical)
- Device class: U
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K072177 (2007). 5 ancestors in all.
16 later devices descend from it; 8 cite it directly.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- 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.
- K112033: Enseal G2 Tissus Sealers, Ethicon Endo-Sugery, LLC (2011)

## Most influential descendants
- K160752: HARMONIC HD 1000i Shears 20 cm Length, HARMONIC HD 1000i Shears 36 cm Length (2016), 6 descendants of its own
- K191555: HARMONIC HD 1000i Shears, 20 cm length, HARMONIC HD 1000i Shears, 36 cm length (2020), 5 descendants of its own
- 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
- K221790: HARMONIC 700 Shears (2023), 1 descendant of its own

## Recalls of this device
- Sep 23, 2015 · Class II · Z-0278-2016: Complaints of holes in Tyvek which can compromise the sterile barrier provided by the packaging.

## Indications for use
The HARMONIC ACE+ Shears with Advanced Hemostasis 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), 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 Advanced Hemostasis hand control button.

Source page: https://510kreport.com/device/K132612
Methodology: https://510kreport.com/methodology