Medigus has announced it has received FDA 510(k) marketing clearance for its SRS endoscopic system, according to a news release.
The device is intended for minimally-invasive endoluminal treatment of GERD.
The endoscope is inserted into the esophagus through the mouth and does not entail incisions into the abdominal cavity. The endoscope features a miniature video camera, ultrasonic sights and a stapling device that enables the physician to perform partial fundoplication.
Medigus already possesses a CE mark for the SRS system.
Medigus is headquartered in Omer, Israel.
Related Articles on FDA Clearances:
Boston Scientific Receives FDA Clearance for Expanded Use Indication for Wire-Guided Balloon Dilator
EndyMed Medical Receives FDA Clearance for Dermatologic Procedure Device
Teleflex Receives FDA Clearance for Epidural Catheter