Device Dossier

Gel Mark Ultra Biopsy Site Marker - Marker, lesion localization, implantable

Device Dossier for Gel Mark Ultra Biopsy Site Marker - Marker, lesion localization, implantable (Marker, lesion localization, implantable, Class III,…

Intended purpose

An implant used to radiographically mark breast tissue during a percutaneous breast biopsy procedure.

Functional description

A disposable applicator containing resorbable polylactic acid/polyglycolic acid (PLA/PGA) pellets with an embedded stainless steel radiopaque wireform, intended for long term radiographic marking of the biospy site. Pellets are visible via ultrasound for approx. 6 weeks and resorbed in approx. 12 weeks. The pellets are deployed from the applicator through the biopsy device into the biopsy cavity.

TGA Public Summary