www.fdanews.com/articles/187426-apollo-endosurgery-cleared-for-endoscopic-suturing-system
Apollo Endosurgery Cleared for Endoscopic Suturing System
June 29, 2018
The FDA granted special 510(k) clearance for Apollo Endosurgery’s OverStitch Sx endoscopic suturing system used for advanced endoscopic surgery.
The device lets physicians place full-thickness sutures from a flexible endoscope, resulting in less invasive solutions for treating defects in the gastrointestinal tract. It can also be used for a number of bariatric procedures.
The special 510(k) clearance addresses an accessory added to the system to improve device attachment to compatible endoscopes.