# K141122: Harmonic Scallop Blade, Generator G11

- Pathway: 510(k) (Traditional)
- Applicant: Ethicon Endo-Surgery, LLC
- Decided: Sep 15, 2014 after 138 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: 8 generations back to K932293 (1994). 57 ancestors in all.
9 later devices descend from it; 2 cite it directly.
0 of 67 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072203: Harmonic 10CM Combination Hook Blade, Ethicon Endo-Surgery, LLC (2007) Summary page 5.
- K101990: Ethicon Endo-Surgery Generator G11, Model GEN11, Ethicon Endo-Sugery, LLC (2011) Summary page 5.
- K081475: Electric Drill System [XPS 4000 System, Midas Rex Legend Ehs System, Integrated Power Console (Ipc)], Medtronic Xomed, Inc. (2008) Summary page 5.
- (no number) Codman® Cobb Spinal Elevator: named in the summary without a submission number

## Most influential descendants
- K160554: Enseal X1 Large Jaw Tissue Sealer (2016), 6 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
- K212614: Ultrasonic Scalpel System (2022), 1 descendant of its own
- K254196: HARMONIC 1100 Shears (HAR1120); HARMONIC 1100 Shears (HAR1136) (2026), 0 descendants of its own

## Indications for use
The Harmonic Scallop Blade 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, gynecologic, exposure to orthopedic structures (such as spine and joint space), ENT (Ears, Nose, Throat), and thoracic surgery, including mobilization of the Internal Mammary Artery (IMA). The Generator G11 provides radiofrequency power to drive EnSeal electrosurgical instruments that are used during open or laparoscopic general and gynecological surgery to cut and seal vessels and to cut, grasp, and dissect tissues. In addition, the generator provides power to drive Harmonic ultrasonic surgical instruments that are indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. EnSeal and Harmonic instruments when used with the Generator G11 have not been shown to be effective for sterilization procedures or tubal coagulation. Do not use these instruments for these procedures.

Source page: https://510kreport.com/device/K141122
Methodology: https://510kreport.com/methodology