XK-95 High Speed Motor Drill System
by Komet Medical 510(k)
Active
510(k) K984035
Overview
The XK-95 High Speed Motor Drill System is a powered drill classified as Drills, Burrs, Trephines & Accessories (Simple, Powered) under product code HBE. It is designed for use in neurological procedures to provide power to operative procedures or attachments.
The device is supplied as a reusable system and was cleared through the FDA 510(k) process under K984035 with a substantially equivalent decision on June 3, 1999. It is classified as a Class II device subject to special controls under regulation 882.4310 and is intended for use in neurology.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK984035 | Date3 Jun 1999 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- 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
- HBE
- Device Class
- Class II
- Regulation
- 21 CFR Part 882.4310
- Advisory Committee
- Neurology
- FDA Decision
- SESE Substantially Equivalent
Other devices from Komet Medical
Questions
What is the XK-95 High Speed Motor Drill System used for?
The XK-95 High Speed Motor Drill System is designed for use in neurological procedures to provide power to operative procedures or attachments, as it is classified under product code HBE for drills, burrs, trephines & accessories (simple, powered) and intended for neurology applications.
Is the XK-95 High Speed Motor Drill System reusable or single-use?
The device is supplied as a reusable system, meaning it is intended for multiple uses after appropriate cleaning and sterilization between procedures, as stated in the device description.
How was the XK-95 High Speed Motor Drill System cleared for market?
The XK-95 High Speed Motor Drill System was cleared through the FDA 510(k) process under submission K984035, receiving a substantially equivalent decision on June 3, 1999, which is the regulatory pathway referenced in the device data.