Monopolar Electrode Surgical Instrument
by VHMED (Nantong) Co., Ltd. EUDAMED510(k)
Active
510(k) K230650
Overview
This device is a monopolar electrode surgical instrument, classified under the product code GEI (General and Plastic Surgery Electrosurgical Devices). It is designed for electrosurgical procedures, delivering controlled electrical energy to tissue for cutting, coagulation, or desiccation during surgical operations.
The instrument is supplied sterile and intended for single-use. It is regulated under FDA 510(k) clearance and the Medical Device Directive (MDD). Compatible for use in standard surgical settings, it requires proper handling and adherence to electrosurgical safety protocols. No MRI safety information is specified.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE 510(k) | NumberK230650 | Date12 Oct 2023 | StatusActive |
| European Union | CE/MDD EUDAMED | Number— | Date— | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
- European Union
- United States
Specification
- 510(k) Number
- FDA Product Code
- GEI
- FDA applicant
- Vhmed (Nantong) Co. , Ltd.
- Device Class
- Class II
- Regulation
- 21 CFR Part 878.4400
- Advisory Committee
- General, Plastic Surgery
- FDA Decision
- SESE Substantially Equivalent
Other devices from VHMED (Nantong) Co., Ltd.
Questions
What types of surgical procedures is this monopolar electrode instrument designed for?
This monopolar electrode surgical instrument is designed for electrosurgical procedures where controlled electrical energy is used to cut, coagulate, or desiccate tissue. It is classified under product code GEI (General and Plastic Surgery Electrosurgical Devices), meaning it is intended for use in general and plastic surgery settings, including any surgical operation where these electrosurgical functions are required.
Is this monopolar electrode instrument reusable or single-use, and how is it supplied?
The monopolar electrode surgical instrument is explicitly intended for single-use only. It is supplied in a sterile condition, ensuring it is ready for immediate use in surgical settings without requiring additional sterilization.
What safety protocols should be followed when using this device in the operating room?
Since this device delivers electrical energy for surgical procedures, it requires adherence to electrosurgical safety protocols to prevent risks like burns or equipment damage. Proper grounding of the patient, correct electrode placement, and following manufacturer guidelines for handling and usage are essential. No MRI safety information is provided, so it should not be used in MRI environments.
What regulatory pathways has this device undergone, and what does that mean for its use?
This monopolar electrode instrument has undergone FDA 510(k) clearance and complies with the Medical Device Directive (MDD). The FDA classification under product code GEI (General and Plastic Surgery Electrosurgical Devices) and the decision code SESE (Substantially Equivalent) indicate that it meets regulatory standards for safety and effectiveness in its intended electrosurgical applications. This means it can legally be marketed and used in the U.S. and EU (under MDD) for its specified purposes.