# K100390: Surgimax/ Surgimax Plus

- Pathway: 510(k) (Traditional)
- Applicant: Elliquence, LLC
- Decided: Aug 25, 2010 after 190 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: 3 generations back to K933157 (1994). 4 ancestors in all.
10 later devices descend from it; 2 cite it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061174: Surgi-Max, Ellman Int'L, Inc. (2006)

## Most influential descendants
- K170107: Surgi Max Ultra (2017), 7 descendants of its own
- 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
- K171869: Sutter CURIS RF Generator (2018), 1 descendant of its own

## Indications for use
Orthopedic. arthroscopic. spinal. and neurosurvical For resection, ablation, and coagulation of soft tissues and hemnostasis of blood vessels in orthopedic, arthroseopic, 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 (RAUIP), myringaotorny with effective hemorrhage control, epistaxis treatment, and turbinate shrinkage, skin incisions, biopsy, cysts, abscesses, tumnors, cosmetic repairs, development of skin flaps, skin tags, Blepharoplasty. Blended Cutting and Coagulation Snoring, Submucosal palatal shrinkage, traditional uvulopalatoplasty (RAUP), myringotormy with effective hemorrhage control. epistaxis treatment, and turbinate shrinkage, skin tags, papillomna ](eloids, Keratosis, Vcrrucae. Basal CellCarcinomLa Nevi, Fistulas, Epithelionma, Cosmetic Repairs, Cysts, Abscesses, Development of skin flaps. H-einostasis and Nonablative Coaguilation Control of bleeding, Epilation, Telangiectasia Bipolar Pinpoint, Precise Coagulation, Pinpoint Hernostasis. in any field (wet or dry), snoring, submucosal palatal shrinkage, traditional uvulopalatoplasty (RAUP), myringotomy with effective hemorrhage control, epistaxis treatment, and turbinate shrinkage.

Source page: https://510kreport.com/device/K100390
Methodology: https://510kreport.com/methodology