# K170107: Surgi Max Ultra

- Pathway: 510(k) (Traditional)
- Applicant: Elliquence, LLC
- Decided: May 3, 2017 after 111 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: 5 generations back to K933002 (1994). 13 ancestors in all.
7 later devices descend from it; 2 cite it directly.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K100390: Surgimax/ Surgimax Plus, Elliquence, LLC (2010) Summary page 5.
- K134054: Bovie Ids-310 High Frequency Electrosurgical Generator, Aaron A3350 High Frequency Electrosurgical Generator, Bovie Medical Corporation (2014) Summary page 5.

## Most influential descendants
- K183611: Soniquence RF Generator and Soniquence Electrodes (2019), 5 descendants of its own
- K212222: Soniquence Reusable 3 Button Fingerswitch Wand (2022), 1 descendant of its own
- K202562: Ellusa Generator, Ellusa Bayonet Tip, Ellusa RF-Cobb Tip, Ellusa SP-Pack and Tips, Ellusa Tip Set (2020), 1 descendant of its own
- K254220: Reusable 3 Button Fingerswitch Wand (2026), 0 descendants of its own
- K222425: Ellusa Reusable Neutral Plates (2022), 0 descendants of its own

## Indications for use
Orthopedic, arthroscopic, spinal, and neurological For resection, ablation, and coagulation of soft tissues and hemostasis of blood vessels in orthopedic, arthroscopic, spinal and neurological procedures. For soft tissue resection and ablation during arthroscopic surgical procedures of knee, shoulder, ankle, elbow, hip and wrist. Cutting Snoring, Submucosal palatal shrinkage, traditional uvulopalatoplasty (RAUP), myringotomy with effective hemorrhage control, epistaxis treatment, and turbinate shrinkage, skin incisions, biopsy, cysts, abscesses, tumors, cosmetic repairs, development of skin flaps, skin tags, Blepharoplasty. Blended Cutting and Coagulation Snoring, Submucosal palatal shrinkage, traditional uvulopalatoplasty (RAUP), myringotomy with effective hemorrhage control, epistaxis treatment, and turbinate shrinkage, skin tags, papilloma Keloids, Keratosis, Verrucae, Basal Cell Carcinoma, Nevi, Fistulas, Epithelioma, Cosmetic Repairs, Cysts, Abscesses, Development of skin flaps. Hemostasis and Nonablative Coagulation Control of bleeding, Epilation, Telangiectasia Bipolar Pinpoint, Precise Coagulation, Pinpoint Hemostasis, in any field (wet or dry), snoring, sub-mucosal palatal shrinkage, traditional uvulopalatoplasty (RAUP), myringotomy with effective hemorrhage control, epistaxis treatment, and turbinate shrinkage.

Source page: https://510kreport.com/device/K170107
Methodology: https://510kreport.com/methodology