Device Dossier
SecurMark for ATEC Biopsy Site Marker - Marker, lesion localization, implantable
Device Dossier for SecurMark for ATEC Biopsy Site Marker - Marker, lesion localization, implantable (Marker, lesion localization, implantable, Class III,…
- GMDN category: Marker, lesion localization, implantable
Intended purpose
The SecurMark biopsy site marker is indicated for the permanent radiographic marking of sites in soft tissue.
Functional description
The SecurMark biopsy site marker is a sterile, single patient use device comprised of a single, biocompatible titanium marker surrounded by a bioabsorbable suture-like material and a deployment device. The deployment device is a hand-held device that delivers the marker from the distal tip. The deployment device consists of a flexible cannula, handle, flexible push rod, and plunger. The marker is located at the distal end of the deployment device.