# K101990: Ethicon Endo-Surgery Generator G11, Model GEN11

- Pathway: 510(k) (Traditional)
- Applicant: Ethicon Endo-Sugery, LLC
- Decided: Jun 13, 2011 after 333 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: 7 generations back to K932293 (1994). 28 ancestors in all.
11 later devices descend from it; 2 cite it directly.
0 of 40 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072177: Enseal Vessel Sealing and Hemostasis System, Surgrx, Inc. (2007) Summary page 1.
- K081129: Enseal Powertip,Nseal-514D,-525D,-535D,-545D,-514RD,-525RD,-535RD,-545RD, Etrio-314D,-325D,-335D,-345D, Enseal Universal, Surgrx, Inc. (2008) Summary page 1.
- K002906: Ultracision Harmonic Scalpel System, Models GEN01, GEN02, GEN03, HP052, HP053, HSA07, Ethicon Endo-Surgery, Inc. (2000) Summary page 1.

## Most influential descendants
- K141122: Harmonic Scallop Blade, Generator G11 (2014), 9 descendants of its own
- 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

## Indications for use
The Generator GIII 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 tissue. 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 GIII 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/K101990
Methodology: https://510kreport.com/methodology