Electrosurgical Cutting and Coagulation Device and Accessories (K061829)
510(k) K061829
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK061829 | Date17 Nov 2006 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Full name
- Electrosurgical Cutting and Coagulation Device and Accessories
- 510(k) Number
- FDA Product Code
- GEI
- Device Class
- Class II
- Regulation
- 21 CFR Part 878.4400
- Advisory Committee
- General, Plastic Surgery
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
This device is an electrosurgical cutting and coagulation system (Product Code: GEI) designed to perform precise tissue dissection and hemostasis using high-frequency electrical currents. It combines cutting and coagulation functions in a single platform, enabling surgeons to control bleeding and excise tissue efficiently during surgical procedures. The system is intended for use in general and plastic surgery applications, where versatility in electrosurgical techniques is required. Accessories are included to enhance functionality, such as suction devices for smoke evacuation during procedures.
The device is supplied as a reusable electrosurgical unit paired with single-use or disposable accessories, including electrodes and suction attachments. It is intended for use in sterile operating room environments and must comply with FDA 510(k) clearance (K061829) under Traditional review. No specific MRI safety classification is stated, and storage conditions are not detailed in regulatory filings. The system is regulated under the General, Plastic Surgery advisory committee and falls under the Electrosurgical, Cutting & Coagulation & Accessories product classification.
Other devices from New Leaf Medical, Inc.
Questions
AI-generated answers, 1 Oct 2026
What is the primary purpose of this electrosurgical device?
This device is designed to perform both precise tissue dissection and hemostasis (bleeding control) during surgical procedures. By combining cutting and coagulation functions in one system, it allows surgeons to efficiently manage bleeding while excising tissue, particularly in general and plastic surgery applications where versatility in electrosurgical techniques is essential.
How is this device supplied, and what type of accessories are included?
The device is supplied as a reusable electrosurgical unit paired with single-use or disposable accessories. These accessories include electrodes for cutting and coagulation, as well as suction attachments to evacuate smoke generated during procedures, enhancing safety and functionality in the operating room.
Is this device intended for single-use or reusable applications?
The electrosurgical unit itself is reusable, while the electrodes and suction attachments are designed as single-use or disposable accessories. This setup ensures sterile use in each procedure while maintaining the durability of the core device for repeated surgical applications.
What surgical specialties is this device intended for?
This device is specifically intended for use in general and plastic surgery. Its design allows surgeons in these fields to perform precise tissue manipulation and hemostasis efficiently, reducing procedural time and improving outcomes.
What regulatory clearance does this device hold, and how was it reviewed?
This device holds FDA 510(k) clearance under the reference number K061829. It was reviewed through the Traditional review pathway and determined to be substantially equivalent to legally marketed devices under the Electrosurgical, Cutting & Coagulation & Accessories product classification (Product Code: GEI).