# K061174: Surgi-Max

- Pathway: 510(k) (Traditional)
- Applicant: Ellman Int'L, Inc.
- Decided: Jun 28, 2006 after 62 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: 2 generations back to K933157 (1994). 3 ancestors in all.
35 later devices descend from it; 3 cite it directly.
0 of 39 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K013255: Surgitron 120 Iec (Also Known as Surgitron 4.0 Dual RF, Ellman Intl., Inc. (2001) Summary page 4.

## Most influential descendants
- K082786: Pulsar Generator, Peak Plasmablade; 4.0, Needle, and Ext Tissue Dissection Devices (2008), 24 descendants of its own
- K100390: Surgimax/ Surgimax Plus (2010), 10 descendants of its own
- K093695: Peak Plasmablade 3.OS Tissue Dissection Device (2010), 8 descendants of its own
- K170107: Surgi Max Ultra (2017), 7 descendants of its own
- K142410: Elliquence Electrodes (2015), 7 descendants of its own

## Indications for use
Orthopedic, arthroscopic, spinal, and neurosurgical 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 Coamilation Snoring, Submucsal 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 Coaizulation Control of bleeding, Epilation, Telangiectasia Bipolar Pinpoint, Precise Coagulation, Pinpoint Hemostasis, 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/K061174
Methodology: https://510kreport.com/methodology