Singapore HSA registration DE0510067
Apollo Endosurgery X-TACK™ Endoscopic HeliX Tacking System
Singapore·CLASS C·Apollo Endosurgery, Inc.·Registered November 22, 2024Device 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 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.
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
About this record
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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