Medicon Vipair High Speed System

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K042974 ↗

FDA Product Code

HBB

Device Class

Class II

Regulation

21 CFR Part 882.4370

Advisory Committee

Neurology

FDA Decision

SESE Substantially Equivalent

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• What surgical applications is the Medicon Vipair High Speed System designed for?

  It is intended for neurosurgical procedures such as craniotomy and spinal surgery, and it can also be used in general surgical applications where high‑speed rotating tools like burs, cutters, and drills are needed.

• How is the system supplied and integrated with instruments?

  The device is provided as a complete motor system that can be integrated with compatible removable surgical instruments. Clinicians select the appropriate tool (e.g., drill or burr) and attach it to the motor for powered operation.

• Is the Medicon Vipair High Speed System a single‑use or reusable device?

  The motor system itself is a reusable component. The rotating surgical tools that attach to it are typically single‑use or reprocessed according to the manufacturer’s instructions, while the motor remains in the operating suite for repeated use.

• What regulatory pathway was used for the device’s clearance?

  The system received FDA 510(k) clearance (K042974) through the traditional pathway in January 2005, classifying it as a Class 2 neurology device (product code HBB).

• How should the system be stored before use?

  The motor system should be stored in a clean, dry environment at the manufacturer’s recommended temperature range, typically in its original packaging until needed, to maintain functionality and sterility of the attached instruments.