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 I-Medix). ARTG record, intended purpose, GMDN…

Intended purpose

A hand-operated, non-electronic, surgical instrument designed for the automatic extraction of a small tissue sample from an anatomical structure (a biopsy), while causing minimal surrounding tissue damage, for tissue pathological examination/test. It consists of both: 1) a handpiece with a spring-loaded mechanism and release trigger; and 2) a percutaneous, distal, needle-like portion with a side-notch cutter which when activated causes a sharp, sliding cannula to slice 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