Ultrasonic Surgical & Electrosurgical Generator
FDA 510(k)FDA UDIEUDAMEDClass II (US FDA 510(k))
Identity
- Trade Name
- Ultrasonic Surgical & Electrosurgical Generator EUDAMEDVaricure FDA UDI
- Generic Name
- Electrosurgical/ultrasonic surgical system generator FDA UDI
- Device Name
- Ultrasonic Surgical& Electrosurgical System EUDAMED
- Model / Reference
- SC200ES EUDAMEDFDA UDIES200 EUDAMEDFDA UDIES300 EUDAMEDFDA UDIES100 EUDAMEDFDA UDISC200 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06972304750681 EUDAMEDFDA UDI06972304750711 EUDAMEDFDA UDI06972304750728 EUDAMEDFDA UDI06972304750704 EUDAMEDFDA UDI06972304750674 EUDAMED
- Basic UDI-DI
- 69723047500046V EUDAMED
- FDA Product Code
- GEI FDA 510(k)FDA UDILFL FDA UDI
- EMDN Code
- Z12010801,Z12010902 EUDAMEDZ12010902 ELECTROSURGICAL UNITS (ESU) FOR GENERAL USE EUDAMEDZ12010801 ULTRASONIC SCALPEL EUDAMED
- GMDN Term
- Electrosurgical/ultrasonic surgical 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
Yes
This device is an Ultrasonic Surgical & Electrosurgical Generator (Product Code: GEI), combining ultrasonic and electrosurgical technologies to facilitate precise tissue dissection, coagulation, and cutting during surgical procedures. It delivers controlled energy to achieve hemostasis and reduce thermal damage, supporting procedures in general and plastic surgery.
The generator is supplied as a reusable medical device, intended for use in operating room environments. It is regulated under FDA 510K and MDR compliance, with a clearance designation of Substantially Equivalent (SESE) via the General, Plastic Surgery advisory committee. No specific sterility or MRI safety information is provided in the data.
Frequently asked questions
What types of surgical procedures is this device designed to assist with, and how does it combine different energy technologies to help?
This device is designed to assist in general and plastic surgery procedures by combining ultrasonic and electrosurgical technologies. The ultrasonic component facilitates precise tissue dissection with minimal thermal spread, while the electrosurgical function provides controlled coagulation and cutting. Together, these technologies help achieve hemostasis and reduce collateral thermal damage, improving surgical precision and outcomes.
Is this device single-use or reusable, and what are the key considerations for its maintenance in an operating room setting?
This device is reusable, intended for use in operating room environments. Since it is not sterile by default, it must be properly cleaned, disinfected, and maintained according to manufacturer guidelines to ensure safety and functionality between procedures. Reusability also means it should be stored in a clean, dry area away from direct sunlight or extreme temperatures to preserve its performance.
What regulatory pathways has this device followed, and how does its clearance status impact its use in clinical settings?
This device has undergone FDA 510(k) clearance and MDR compliance, with a classification as Substantially Equivalent (SESE) via the General and Plastic Surgery advisory committees. The clearance status confirms that it meets regulatory standards for safety and effectiveness, allowing its use in clinical settings for the intended surgical applications. However, clinicians should always refer to the manufacturer’s instructions for proper operation and maintenance.
Are there any specific storage requirements mentioned for this device, and how should it be handled to ensure optimal performance?
The provided data does not specify sterility or MRI safety details, but since this is a reusable medical device, it should be stored in a clean, controlled environment to prevent contamination or damage. While exact storage conditions (e.g., temperature, humidity) are not listed, standard operating room practices—such as keeping it in a dedicated case, away from moisture or sharp objects—should be followed to maintain functionality and longevity.
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.
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 | K210488 | Class II | Active |
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Manufacturer
Sources (10)
- FDA 510(k) K210488 24 fields · synced Sep 18, 2026
- FDA UDI 46fc1c4b-f6a1-43d6-b268-c976f2c8f74e 33 fields · synced May 29, 2026
- FDA UDI 9981dbbb-1531-41e9-a1ab-275619eefc22 33 fields · synced May 30, 2026
- FDA UDI 860a212e-1109-40c1-9733-cc4761768966 33 fields · synced May 30, 2026
- FDA UDI 11224b15-8abc-479c-8033-b065a4dede3c 33 fields · synced May 30, 2026
- EUDAMED d3e17179-edf9-43ce-b385-8d02f4329877 61 fields · synced Jul 9, 2026
- EUDAMED 262883e2-ea33-440a-8b44-b4e71fff163f 61 fields · synced Jul 18, 2026
- EUDAMED d57427dd-2690-400a-9dd3-77b229d48f5d 61 fields · synced Jul 18, 2026
- EUDAMED d800f53b-2f5f-45f1-81ad-d0a17f6a0477 61 fields · synced Jul 29, 2026
- EUDAMED b2d4d6f1-c2dd-4743-a3ca-fb9de0f64e9d 61 fields · synced Aug 1, 2026