# K171869: Sutter CURIS RF Generator

- Pathway: 510(k) (Traditional)
- Applicant: Sutter Medizintechnik GmbH
- Decided: Feb 23, 2018 after 246 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: 4 generations back to K933157 (1994). 5 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 7 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.

## Most influential descendants
- K251813: CURIS II RF Generator (REF 360100-05) (2026), 0 descendants of its own

## Indications for use
Orthopedic, arthroscopic, spinal and neurosurgical: For resection and coagulation of soft tissues and hemostasis of blood vessels in orthopedic, arthroscopic, spinal and neurosurgical procedures. For soft tissue resection and coagulation 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, Teleangiectasia. 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. Contraindications: This device is not intended for vessel sealing.

Source page: https://510kreport.com/device/K171869
Methodology: https://510kreport.com/methodology