Device Dossier

Disposable Biopsy Needle Kit for Leksell Stereotactic System, Model 911933. - Biopsy kit, brain

Device Dossier for Disposable Biopsy Needle Kit for Leksell Stereotactic System, Model 911933. - Biopsy kit, brain (Biopsy kit, brain, Class III, sponsor…

Intended purpose

The Disposable Biopsy Needle Kit is designed for performing brain biopsies using Leksell Stereotactic System®. This device should only be used by a physician/surgeon trained in the use of Leksell Stereotactic System® and brain biopsy needle devices and procedures.

Functional description

These needles are an alternative to reusable biopsy needles addressing concerns regarding cross?contamination. The kit includes a disposable sidecutting biopsy needle with an 8.0 mm needle window and an aspiration tube. The kit also includes a disposable Stop and Guide to further reduce the risk of crosscontamination.

TGA Public Summary