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,…

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.

TGA Public Summary