Device Dossier
Endotherapy guidewire, single-use
Device Dossier for Endotherapy guidewire, single-use (Endotherapy guidewire, single-use, Class IIa, sponsor Device Technologies). ARTG record, intended…
- GMDN category: Endotherapy guidewire, single-use
- Sponsor: Device Technologies
Intended purpose
An endotherapy device used in combination with a compatible flexible endoscope to assist in the insertion of an endoscope or endotherapy devices, (e.g., stent-placement devices, electrosurgical devices, or catheters) during diagnostic and therapeutic endoscopy. It is typically used within the gastrointestinal (GI) tract and is made of a flexible metal coil or wire coated with a plastic material [e.g., polytetrafluoroethylene (PTFE), commonly known as Teflon, or polyethylene]. It may have radiopaque graduated markings at the distal end to assist in the fluoroscopic monitoring of its advancement/position within the body.