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Apollo Endosurgery X-TACK™ Endoscopic HeliX Tacking System - HSA Registration DE0510067

Access comprehensive regulatory information for Apollo Endosurgery X-TACK™ Endoscopic HeliX Tacking 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 DE0510067 and owned by Apollo Endosurgery, Inc.. The device was registered on November 22, 2024.

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
DE0510067
Apollo Endosurgery X-TACK™ Endoscopic HeliX Tacking System
HSA Registration Number: DE0510067
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Product Description

The X-Tack™ System is intended for approximation of soft tissue in minimally invasive gastroenterology procedures (e.g. closure and healing of ESD/EMR sites, and closing of fistula, perforation or leaks). The X-Tack™ System is not intended for hemostasis of acute bleeding ulcers.

Device Classification
Device Class
CLASS C
Medical Speciality Area
Gastroenterology & Urology
Registration Information
Registration Number
DE0510067
Registration Date
November 22, 2024
Retention Due Date
November 21, 2025
Product Owner
Short Name
Apollo Endosurgery, Inc.
Address
1120 S Capital of Texas Hwy., Building 1, Suite 300, Austin, Texas 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)
Suture Cinch - Long OverStitch™ Suture Cinch X-TACK Endoscopic HeliX Tacking System (160cm) X-TACK Endoscopic HeliX Tacking System (235cm)
Model Identifier(s)
CNH-C01-213-L CNH-G01-000 XTACK-160-H XTACK-235-H