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Singapore HSA registration DE0510649

Apollo Endosurgery OverStitch NXT™ Endoscopic Suturing System

Singapore flagSingapore·CLASS C·Apollo Endosurgery, Inc.·Registered April 29, 2025
Device classification
Device Class
CLASS C
Medical Speciality Area
Gastroenterology & Urology
Registration information
Registration Number
DE0510649
Registration Date
April 29, 2025
Retention Due Date
April 28, 2026
Product 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.
Product Owner
Name
Apollo Endosurgery, Inc.
Short Name
Apollo Endosurgery, Inc.
Address
1120, South Capital of Texas Highway, Building 1, Suite 300, Austin, TX 78746, UNITED STATES
Registrant
Name
BOSTON SCIENTIFIC ASIA PACIFIC PTE. LTD.
Address
9 NORTH BUONA VISTA DRIVE, THE METROPOLIS TOWER ONE, #20-01, SINGAPORE 138588
Importer
Name
BOSTON SCIENTIFIC ASIA PACIFIC PTE. LTD.
Address
9 NORTH BUONA VISTA DRIVE, THE METROPOLIS TOWER ONE, #20-01, SINGAPORE 138588
Model information
Model Name(s)
OverStitch™ Suture Cinch Assembly OverStitch NXT™ Endoscopic Suturing System NXT Tissue Helix Pro Apollo OverStitch™ 2-0 Polypropylene Suture Tissue Helix
Model Identifier(s)
CNH-G01-000 ESS-G02-NXT NXT-THXP-130 PLY-G02-020-APL THX-165-028
About this record

Access comprehensive regulatory information for Apollo Endosurgery OverStitch NXT™ Endoscopic Suturing System in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0510649 and owned by Apollo Endosurgery, Inc.. The device was registered on April 29, 2025.

This page provides complete registration details including product owner information, registrant details, importer information, and regulatory compliance data from the official Singapore HSA medical device database. Pure Global AI offers free access to Singapore's complete medical device registry, helping global MedTech companies navigate HSA regulations efficiently.

Free DatabasePowered by Pure Global AIHSA Official DataCLASS C