Device Dossier
Endotherapy needle, single use
Device Dossier for Endotherapy needle, single use (Endotherapy needle, single use, Class IIa, sponsor Medtronic). ARTG record, intended purpose, GMDN…
- GMDN category: Endotherapy needle, single use
Intended purpose
The fine needle aspiration biopsy system is intended to be used for sampling submucosal and extramural gastrointestinal lesions through the instrument channel of an Endoscopic Ultrasound Endoscope. The needle is designed with a passive (i.e., automatic) safety shielding feature to aid in the prevention of needle stick injury.