Device Dossier

Malleable Suction - Stereotactic surgery system, multi-purpose

Device Dossier for Malleable Suction - Stereotactic surgery system, multi-purpose (Stereotactic surgery system, multi-purpose, Class III, sponsor…

Intended purpose

The Malleable Suction Instruments is an electromagnetically tracked handheld, sterile, single-use cannula designed to be used with standard surgical vacuum systems for the removal of fluids, semi-fluid substances, tissue, and bone dust. The system and its associated applications should be used only as an adjunct for surgical guidance. They do not replace the surgeon's knowledge, expertise, or judgement.