Sutter CURIS RF Generator
FDA 510(k)FDA UDIEUDAMEDClass II (US FDA 510(k))
Identity
- Trade Name
- Sutter FDA UDI
- Generic Name
- Electrosurgical system generator FDA UDI
- Device Name
- Generators EUDAMEDRF-Generator CURIS® BM 1700 mono-/ bipolar incl. power cord, operating instruction, FDA UDISynergy Electrosurgery RF Generator Distributed by Arthrex FDA UDI
- Model / Reference
- 360100-03 EUDAMEDFDA UDIAR-S9800 EUDAMEDFDA UDIAR-S9800-1 EUDAMED360100-05 EUDAMED360080-01 EUDAMED
- Description
- RF-Generator CURIS® BM 1700 mono-/ bipolar incl. power cord, operating instruction, FDA UDISynergy Electrosurgery RF Generator Distributed by Arthrex FDA UDI
Identifiers
- Catalog Number
- 360100-03 FDA UDIAR-S9800 FDA UDI
- Primary DI / UDI-DI
- ESUM360100030 EUDAMEDFDA UDIESUMARS98000 EUDAMEDFDA UDIESUMARS980010 EUDAMEDESUM360100050 EUDAMEDESUM360080010 EUDAMED
- Basic UDI-DI
- ++ESUMTD09360100EW EUDAMED
- Direct Marketing DI
- ESUMARS98000 EUDAMEDESUMARS980010 EUDAMEDESUM360100030 EUDAMEDESUM360100050 EUDAMEDESUM360080010 EUDAMED
- 510(k) Number
- K171869 FDA 510(k)
- FDA Product Code
- GEI FDA 510(k)FDA UDI
- EMDN Code
- Z12010902 ELECTROSURGICAL UNITS (ESU) FOR GENERAL USE EUDAMED
- GMDN Term
- Electrosurgical system generator FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA 510(k)FDA UDI
- Legislation / Framework
- 21 CFR Part 878.4400 FDA 510(k)
- Regulation Number
- 878.4400 FDA 510(k)FDA UDI
- Market of Registration
- Germany EUDAMED
- Advisory Committee
- General, Plastic Surgery FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
Yes
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
No
Serial Number
Yes
Expiration Date
No
Manufacturing Date
No
The Sutter CURIS RF Generator is a radiofrequency (RF) device designed for controlled tissue ablation and coagulation, primarily used in plastic surgery procedures. It delivers precise RF energy to achieve hemostasis, tissue shrinkage, or volume reduction in soft tissues, aiding in surgical interventions such as liposuction or skin tightening.
This device is supplied as a reusable medical instrument, intended for use in clinical settings such as operating rooms or outpatient surgical facilities. It is regulated under the FDA’s 510(k) clearance process (K171869) and complies with the Medical Device Regulation (MDR). The generator operates within defined safety parameters and requires proper calibration and maintenance to ensure consistent performance, as outlined in its specifications.
Frequently asked questions
What types of surgical procedures is the Sutter CURIS RF Generator primarily intended for in plastic surgery?
The Sutter CURIS RF Generator is designed for controlled tissue ablation and coagulation, making it particularly useful in procedures like liposuction and skin tightening. Its radiofrequency energy helps achieve hemostasis (stopping bleeding), tissue shrinkage, or volume reduction in soft tissues, which are key aspects of these plastic surgery interventions.
Is the Sutter CURIS RF Generator a single-use or reusable device, and what does this mean for maintenance?
The Sutter CURIS RF Generator is a reusable medical instrument, meaning it is built for repeated use in clinical settings like operating rooms or outpatient facilities. Since it is reusable, proper calibration and maintenance are required to ensure consistent performance and safety, as outlined in the device’s specifications.
How is the Sutter CURIS RF Generator regulated, and what does this mean for its use in clinical settings?
The device is regulated under the FDA’s 510(k) clearance process (K171869) and complies with the Medical Device Regulation (MDR). This means it has undergone evaluation to demonstrate substantial equivalence to a legally marketed predicate device, ensuring it meets safety and effectiveness standards for use in controlled surgical environments like operating rooms or outpatient facilities.
What clinical settings is the Sutter CURIS RF Generator intended for, and why?
The device is intended for use in clinical settings such as operating rooms or outpatient surgical facilities. This is because it is a reusable medical instrument designed for controlled tissue ablation and coagulation, requiring proper infrastructure and trained personnel to ensure safe and effective application in surgical environments.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Sutter (Unternehmen) – Wikipedia, Sutter Medizintechnik
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K171869 | Class II | Active |
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Manufacturer
- Manufacturer
- Sutter Medizintechnik GmbH
Sources (8)
- FDA 510(k) K171869 24 fields · synced Sep 18, 2026
- FDA UDI 00a11b70-9053-4cbd-876a-03d578e3a67a 35 fields · synced May 29, 2026
- FDA UDI 2dd386b2-4114-4ca3-8b43-840cffde4924 35 fields · synced May 30, 2026
- EUDAMED e882b40f-23bb-4ec2-95d6-9c94e84f508e 61 fields · synced Jul 9, 2026
- EUDAMED 91a7e176-4fc1-4612-98a2-fa8375a46378 61 fields · synced Jul 14, 2026
- EUDAMED bb5fddcb-8df8-4528-8d78-4c3087778bca 61 fields · synced Jul 25, 2026
- EUDAMED 9a77b6c4-ee28-4f23-93bc-8a0e94cf8b26 61 fields · synced Jul 30, 2026
- EUDAMED fab4d593-a885-4edf-b6d7-7c95786493fb 61 fields · synced Jul 31, 2026