HSA · registration DE0510649Boston Scientific OverStitch NXT™ Endoscopic Suturing System
SingaporeGastroenterology & UrologyClass CBoston Scientific Coporation
Official record identity
- Registration number
- DE0510649
- Model name
- OverStitch NXT™ Endoscopic Suturing System; OverStitch™ 2-0 Polypropylene Suture; Tissue Helix; NXT Tissue Helix Pro; OverStitch™ Suture Cinch Assembly
- Model identifier
- M00505420; M00505441; M00505470; M00505480; M00505540
- Registration date
- April 29, 2025
- Source update date
- January 28, 2026
Classification
- Risk class
- Class C
Official value: CLASS C
Published parties
- Product owner
- Boston Scientific Coporation
- Registrant / registration holder
- BOSTON SCIENTIFIC ASIA PACIFIC PTE. LTD.
Official description
The OverStitch NXT 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.
Additional source fields
- Product owner address
- 300 Boston Scientific Way, Marlborough, MA01752-1234, United States
- Registrant address
- 9 NORTH BUONA VISTA DRIVE, #20-01, THE METROPOLIS, Singapore 138588
About this record
This page mirrors one row from HSA’s official registered-medical-device workbook. Product owner and registrant are separate published roles; neither is relabeled as the manufacturer. The official NOT_GENERATED value is retained when HSA does not publish a registration number, and the device name remains part of the stable record identity.