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CURIS II RF Generator (REF 360100-05)

Sutter Medizintechnik GmbH

Country / Region:Germany (DE)Submission type:Traditional

Product code GEI· 21 CFR 878.4400

Summary PDF

Company

Germany (DE)

Product code

GEI
21 CFR 878.4400

Predicate devices

2

Cited as predicate

0

Device details

FDA 510(k) registration fields

K number
K251813
Device name
CURIS II RF Generator (REF 360100-05)
Country / Region
Germany(DE)
Product code
GEI
Device class
Class 2
Regulation number
21 CFR 878.4400
Date received
2025-06-13
Decision date
2026-02-11
Submission type
Traditional
Technology type
RF Generator(AI inferred)
Clinical applications
SurgeryTissue RepairPain ManagementOther
Primary application
Surgery
Classification source
AI classified

Indications for Use

The Sutter CURIS® II RF Generator is intended for: 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.

Intended Use

The Sutter CURIS® II RF Generator is intended for: 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, 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.

Device Description

The Sutter CURIS® II RF Generator is a compact source of high radiofrequency ("RF") energy to be employed for a variety of electrosurgical procedures. This is achieved by the selection of different waveforms and power levels on the front panel of the device. All selections are activated through pushbuttons and knobs. Lamps give the operator feedback on the status. The power level for each mode is indicated by the front-panel digital displays. During self-test or for error messages these digital displays also serve as indicators. Activation of output power is performed through foot switch and/or hand switch. Monopolar and bipolar electrodes and instruments from Sutter Medizintechnik GmbH or other manufacturers are available for use. The maximum power output of the device in CUT mode is 120 Watt at 700 Ohm load, and 80 Watt maximum in COAG mode at 60 Ohm. Operating frequency of the device is maintained at 4.0 MHz. Model number Component Description REF 360100–05 Sutter CURIS® II RF Generator Device including power cord and Instruction manual.

Summary parsed at:2026-06-19 23:51:09 UTC

Predicate devices

2

K251813 references 2 predicate/reference devices

Cited as predicate

0

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