Device Category Dossier

Non-implantable needle guide, single-use

Device Category Dossier for Non-implantable needle guide, single-use. Australian ARTG records, sponsors, device class — compiled by arcimedes.

Needle guides are sterile devices designed to lead a needle into its proper course when performing clinical and/or surgical procedures , with rigid, non-powered construction that directs a sharp needle into its proper trajectory . These devices assist in manual positioning of needles for ultrasound-guided transrectal or transperineal prostate biopsies, focal therapies such as cryotherapy, and low-dose and high-dose rate brachytherapy of the prostate , and are also available for procedures including urethral injections, ultrasound-guided percutaneous punctures, nerve blocks, and stereotactic breast biopsies .