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…
- GMDN category: Stereotactic surgery system, multi-purpose
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.