Electrosurgery Pencil, Model 767
by Birtcher Corp. 510(k)
Active
510(k) K860718
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK860718 | Date24 Mar 1986 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 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
The Electrosurgery Pencil, Model 767, is a device classified under the product code GEI (General and Plastic Surgery Electrosurgical Devices). It is designed for electrosurgical procedures, delivering controlled electrical currents to cut or coagulate tissue during surgical operations. This handheld instrument is intended for use in outpatient clinics, hospitals, and operating rooms where precision cutting and sealing of soft tissues are required. Its design aligns with traditional electrosurgical tools, ensuring compatibility with existing surgical workflows.
The Electrosurgery Pencil, Model 767, is supplied as a reusable device and is intended for single-user or shared-use settings under sterile conditions. It operates within standard electrosurgical systems and is not labeled for MRI use. The device is cleared under FDA 510(k) authorization (K860718) and was reviewed by the Surgical Devices Panel (SU) in 1986. Storage and maintenance instructions are detailed in the manufacturer’s documentation, emphasizing proper cleaning and sterilization protocols to ensure safe, repeated use in surgical environments.
Other devices from Birtcher Corp.
Questions
AI-generated answers, 1 Oct 2026
What is the Electrosurgery Pencil Model 767 used for?
The Birtcher Electrosurgery Pencil Model 767 is designed for electrosurgical procedures, providing controlled electrical currents to cut or coagulate soft tissue during surgeries. It is intended for use in outpatient clinics, hospitals, and operating rooms where precision cutting and sealing of tissues are required, ensuring compatibility with existing surgical workflows.
Is the Electrosurgery Pencil Model 767 reusable or single-use?
The Model 767 is a reusable device, intended for single-user or shared-use settings under sterile conditions. Proper cleaning and sterilization are required between uses to maintain safety and functionality in surgical environments.
What are the key specifications for the Electrosurgery Pencil Model 767?
The device falls under FDA product code GEI (General and Plastic Surgery Electrosurgical Devices) and was cleared under FDA 510(k) authorization (K860718). It operates within standard electrosurgical systems and is not labeled for MRI use. The device was reviewed by the Surgical Devices Panel (SU) in 1986 and is classified as substantially equivalent.
How should the Electrosurgery Pencil Model 767 be stored and maintained?
Storage and maintenance instructions are provided in the manufacturer’s documentation, emphasizing proper cleaning and sterilization protocols to ensure safe, repeated use. Adhering to these guidelines is essential for maintaining the device’s performance and longevity in surgical settings.
Can the Electrosurgery Pencil Model 767 be used with any electrosurgical system?
Yes, the Model 767 is designed to be compatible with standard electrosurgical systems, ensuring seamless integration into existing surgical workflows. However, it is not labeled for use in MRI environments.