Device Dossier

Cryosurgical system handpiece tip

Device Dossier for Cryosurgical system handpiece tip (Cryosurgical system handpiece tip, Class IIb, sponsor Surgeons Choice). ARTG record, intended…

Intended purpose

A sterile component of a cryosurgical system intended to be attached to a cryosurgical system handpiece to deliver liquid refrigerant (cryogen) [e.g., liquid nitrogen (LN2), nitrous oxide (N2O), carbon dioxide (CO2)] percutaneously for cryotherapy applications (e.g., analgesia, surgical ablation, dermatology). It is typically a closed-end needle intended to deliver focused cooling to the therapy site without destroying healthy tissues. This is a single-use device.

TGA Public Summary