HSA · registration DE0510067Apollo Endosurgery X-TACK™ Endoscopic HeliX Tacking System
SingaporeGastroenterology & UrologyClass CApollo Endosurgery, Inc.
Official record identity
- Registration number
- DE0510067
- Model name
- Suture Cinch - Long; OverStitch™ Suture Cinch; X-TACK Endoscopic HeliX Tacking System (160cm); X-TACK Endoscopic HeliX Tacking System (235cm)
- Model identifier
- CNH-C01-213-L; CNH-G01-000; XTACK-160-H; XTACK-235-H
- Registration date
- November 22, 2024
Classification
- Risk class
- Class C
Official value: CLASS C
Published parties
- Product owner
- Apollo Endosurgery, Inc.
- Registrant / registration holder
- BOSTON SCIENTIFIC ASIA PACIFIC PTE. LTD.
Official 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.
Additional source fields
- Product owner address
- 1120 S Capital of Texas Hwy., Building 1, Suite 300, Austin, Texas 78746, 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.