Electrosurgical Monopolar Handswitching Pencil W/Removable Blade
by Debusk Technology Corp. 510(k)
Active
510(k) K940909
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK940909 | Date30 Mar 1994 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Recalls
-
- Terminated Z-1583-2018
Non-sterile product was packaged inside a case that was labeled as sterile.
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 Electrosurgical Monopolar Handswitching Pencil With Removable Blade is a medical device designed for electrosurgical procedures. It features a handswitching mechanism and a removable blade electrode for various surgical applications.
This device is supplied as a single-use or reusable item depending on the specific model. It is intended for use in electrosurgical procedures and has received FDA 510(k) clearance with K number K940909. The device is available in various configurations with different blade options and cord lengths.
Other devices from Debusk Technology Corp.
Questions
AI-generated answers, 1 Oct 2026
What is the Electrosurgical Monopolar Handswitching Pencil with Removable Blade used for?
This device is designed for electrosurgical procedures and features a handswitching mechanism with a removable blade electrode that can be used for various surgical applications depending on the specific model and blade configuration selected.
Is this device supplied as single-use or reusable?
The Electrosurgical Monopolar Handswitching Pencil with Removable Blade is supplied as either a single-use or reusable item depending on the specific model purchased, with different configurations available to meet various clinical needs.
What regulatory clearance has this device received?
This device has received FDA 510(k) clearance with K number K940909, determined to be substantially equivalent to predicate devices in the General and Plastic Surgery advisory committee review category.
What options are available for this electrosurgical pencil?
The device is available in various configurations with different blade options and cord lengths to accommodate different surgical requirements and preferences, though specific model details would need to be confirmed with the manufacturer.