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Apollo Endosurgery OverStitch NXTโ„ข Endoscopic Suturing System - HSA Registration DE0510649

Access comprehensive regulatory information for Apollo Endosurgery OverStitch NXTโ„ข 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.

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CLASS C
DE0510649
Apollo Endosurgery OverStitch NXTโ„ข Endoscopic Suturing System
HSA Registration Number: DE0510649
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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.

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 Owner
Short Name
Apollo Endosurgery, Inc.
Address
1120, South Capital of Texas Highway, Building 1, Suite 300, Austin, TX 78746, UNITED STATES
Registrant
Address
9 NORTH BUONA VISTA DRIVE, THE METROPOLIS TOWER ONE, #20-01, SINGAPORE 138588
Importer
Address
9 NORTH BUONA VISTA DRIVE, THE METROPOLIS TOWER ONE, #20-01, SINGAPORE 138588
Model Information
Model Name(s)
OverStitchโ„ข Suture Cinch Assembly OverStitch NXTโ„ข Endoscopic Suturing System NXT Tissue Helix Pro Apollo OverStitchโ„ข 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