Device Dossier
Suture/needle passer, single-use
Device Dossier for Suture/needle passer, single-use (Suture/needle passer, single-use, Class IIa, sponsor Boston Scientific). ARTG record, intended…
- GMDN category: Suture/needle passer, single-use
Intended purpose
The OverStitch Endoscopic Suture System is indicated for the endoscopic placement of anchor-sutures. Anchor-sutures can be placed for defect closure (e.g. perforation, ESD/EMR and fistula/leak), stent fixation to reduce migration rates in the upper GI tract, endoscopic sleeve gastroplasty, and transoral outlet reduction.