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 Innologic). ARTG record, intended purpose,…

Intended purpose

A sterile hand-operated surgical instrument designed for the automatic extraction of a small tissue sample from an anatomic structure of the body (i.e., a biopsy), while causing minimal surrounding tissue damage, for pathological examination/testing. It has a spring-loaded mechanism intended for transcutaneous insertion of its distal needle-like portion. It typically has a trocar-like distal tip with a side-notch cutter; when activated, a sharp, sliding cannula slices a segment of tissue. It is typically used to obtain samples of soft tissue from the kidneys, prostate, pancreas, liver, and breast, often performed under image guidance. This is a single-use device

TGA Public Summary