Device Dossier

Forceps, biopsy

Device Dossier for Forceps, biopsy (Forceps, biopsy, Class IIa, sponsor Trewavis Surgical Instruments). ARTG record, intended purpose, GMDN category —…

Intended purpose

This instrument has been specifically designed to provide rectal biopsy specimens for accurately establishing the absence of ganglion cells in the submucosal plexus to aid in the diagnosis of Hirschsprung’s disease. This device is supplied sterile and single use only.

TGA Public Summary