Single Use Electrosurgical Knife with Fluid Pump System
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identity
- Device Name
- Single Use Electrosurgical Knife EUDAMED
- Model / Reference
- MK-I-1-165-N EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06902284542372 EUDAMED
- Basic UDI-DI
- 6902284MK58039HV EUDAMED
- 510(k) Number
- K211172 FDA 510(k)
- FDA Product Code
- GEI FDA 510(k)
- EMDN Code
- K0201010302 LAPAR AND THORACOSCOPIC ELECTROSURGERY ELECTRODES, SINGLE-USE EUDAMED
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 878.4400 FDA 510(k)
- Regulation Number
- 878.4400 FDA 510(k)
- Market of Registration
- Germany EUDAMED
- Advisory Committee
- General, Plastic Surgery FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Clinical & Handling
Sterile
Yes
Implantable
No
Reusable
No
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
This device is a single-use electrosurgical knife with an integrated fluid pump system, classified under the FDA product code GEI (General and Plastic Surgery Electrosurgical Devices). It is designed for endoscopic procedures, delivering high-frequency electrosurgical energy to cut and coagulate tissue while facilitating fluid irrigation to enhance visibility and reduce thermal damage.
The device is intended for single-use only and requires connection to an electrosurgical unit (ESU) for operation. Supplied sterile, it is regulated under FDA 510(k) clearance (K211172) and MDR compliance, with no third-party certification indicated. No MRI safety classification or reusable components are specified, and storage conditions must adhere to manufacturer guidelines for sterile single-use instruments.
Frequently asked questions
What types of surgical procedures is this device designed for, and why is the fluid pump system important during those procedures?
This device is designed specifically for endoscopic procedures in general and plastic surgery, where precise cutting and coagulation of tissue are required. The integrated fluid pump system is crucial because it delivers irrigation fluid to the surgical site, which helps improve visibility by reducing smoke and blood, while also minimizing thermal damage to surrounding tissues during electrosurgical use.
Is this device reusable, or is it meant for single-use only? How does that affect its sterility and handling?
This device is intended for single-use only, meaning it should not be reused after a single procedure. It is supplied sterile, so no additional sterilization is required before use. This design reduces the risk of contamination and ensures consistent performance, but it also means each procedure requires a new device, which should be handled with care to maintain sterility until use.
What kind of electrosurgical unit (ESU) does this device require, and how is it connected?
This device requires connection to a compatible electrosurgical unit (ESU) for operation, as it does not function independently. The exact connection method (e.g., cable type, interface) would be detailed in the manufacturer’s instructions, but generally, it would involve plugging into the ESU’s output port to deliver high-frequency energy while the integrated fluid pump system operates alongside it.
Are there specific storage instructions for this device, and why are they important?
The device must be stored according to the manufacturer’s guidelines for sterile single-use instruments, which typically include keeping it in its original packaging, away from extreme temperatures, moisture, or direct sunlight. Proper storage ensures sterility is maintained until use, preventing contamination that could compromise surgical safety or device performance.
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: Single Use Electrosurgical Knife with Fluid Pump System, Single Use Electrosurgical Knife With Fluid Pump System, Micro-Tech Single Use Electrosurgical Knife - SAGES, K211172 - Single Use Electrosurgical Knife with F...
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 | K211172 | Class II | Active |
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Manufacturer
- Manufacturer
- Micro-Tech (Nanjing) Co., Ltd.
Sources (2)
- FDA 510(k) K211172 24 fields · synced Sep 30, 2026
- EUDAMED d03b2684-84ae-4853-ac6e-ab4c0f3d53ab 61 fields · synced Sep 17, 2026