Details
Device typeGastro-oesophageal antireflux fundal implant placement tool, single-use: An invasive device designed for the implantation of a gastro-oesophageal antireflux fundal implant (e.g., space-occupying extraluminal implant, intraluminal clip/fastener) used to help prevent hiatal hernia and gastro-oesophageal reflux. It is introduced into the body during a luminal endoscopic (e.g., transoral) or laparoscopic intervention and typically consists of a manually-operated trocar or endoscopic implant grasping/releasing insertion tool. This is a single-use device.
FDA categoryEndoscopic suture/plication system, gastroesophageal reflux disease (gerd)
Device ID00884450848111
Catalog numberR2007
AvailabilityPrescription
Single useYes
SterileYes
MRI safetyMR Unsafe