Device Dossier

Side-notch biopsy gun, single-use

Device Dossier for Side-notch biopsy gun, single-use (Side-notch biopsy gun, single-use, Class IIa, sponsor Hologic (Australia & New Zealand)). ARTG…

Intended purpose

The biopsy needle primarily consists of a hollow needle with a side aperture and a sharpened inner cannula that is used to remove breast tissue in a minimally invasive manner using stereotactic or tomosynthesis imaging. The biopsy needle is single-use and is disposable.

TGA Public Summary