Komet XK-95 Perforator Motor (MI-102)
by Komet Medical 510(k)
Active
510(k) K991625
Overview
The Komet XK-95 Perforator Motor (MI-102) is a pneumatic motor, drill designed for neurosurgical applications. It serves as a motor drive unit for cranial perforators, enabling the creation of burr holes in the skull during surgical procedures. This device is classified under the nomenclature for motor-driven surgical instruments and is intended for use in operating room environments by trained surgeons.
The device is supplied as a reusable, non-sterile instrument and is regulated under FDA 510(k) clearance (K991625) as a Class 2 Neurology device with product code HBB. It operates in conjunction with compatible cranial perforators via an adapter and is intended for use in neurosurgical settings. Storage and handling follow standard surgical instrument protocols, with no specific sterility requirements stated beyond typical preoperative cleaning and sterilization procedures.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK991625 | Date30 Jul 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- Withdrawn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
- HBB
- Device Class
- Class II
- Regulation
- 21 CFR Part 882.4370
- Advisory Committee
- Neurology
- FDA Decision
- SESE Substantially Equivalent
Other devices from Komet Medical
Questions
What is the Komet XK-95 Perforator Motor (MI-102) used for?
The Komet XK-95 Perforator Motor (MI-102) is a pneumatic motor specifically designed for neurosurgical applications. It serves as a motor drive unit for cranial perforators, enabling surgeons to create burr holes in the skull during cranial procedures. This device is intended for use in operating rooms by trained surgeons performing neurosurgical interventions.
Is the Komet XK-95 Perforator Motor (MI-102) reusable or single-use?
The Komet XK-95 Perforator Motor (MI-102) is supplied as a reusable instrument. It is not intended for single-use and must follow standard surgical instrument protocols for cleaning and sterilization between procedures. Proper maintenance ensures its reliability and safety in neurosurgical settings.
How is the Komet XK-95 Perforator Motor (MI-102) supplied?
The device is supplied in a non-sterile condition. It requires preoperative cleaning and sterilization before use in surgical procedures. This aligns with standard practices for reusable surgical instruments to prevent contamination and ensure patient safety.
What compatibility does the Komet XK-95 Perforator Motor (MI-102) have with other devices?
The Komet XK-95 Perforator Motor (MI-102) operates in conjunction with compatible cranial perforators via an adapter. It is specifically designed for neurosurgical applications and should only be used with instruments intended for this purpose to maintain functionality and safety.
What regulatory pathway does the Komet XK-95 Perforator Motor (MI-102) follow?
The Komet XK-95 Perforator Motor (MI-102) is regulated under the FDA 510(k) clearance process as a Class 2 Neurology device with product code HBB. It was granted clearance under the Traditional 510(k) pathway, with a decision date of July 30, 1999, and is classified as substantially equivalent to predicate devices.