Singapore HSA registration DE0505552
Apollo Endosurgery OverStitch Sx™ Endoscopic Suturing System
Singapore·CLASS C·Apollo Endosurgery, Inc.·Registered March 10, 2021Device classification
- Device Class
- CLASS C
- Medical Speciality Area
- Gastroenterology & Urology
Registration information
- Registration Number
- DE0505552
- Registration Date
- March 10, 2021
- Change Notification Approval Date
- March 05, 2025
- Retention Due Date
- March 09, 2026
Product description
The OverStitch 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
- 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 37 UBI CRESCENT, SINGAPORE 408586
Model information
- Model Name(s)
- OverStitch™ Suture Cinch OverStitch Sx™ Endoscopic Suturing System OverStitch™ 2-0 Polypropylene Suture Tissue Helix
- Model Identifier(s)
- CNH-G01-000 ESS-G02-Sx1 PLY-G02-020-APL THX-165-028
About this record
Access comprehensive regulatory information for Apollo Endosurgery OverStitch Sx™ 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 DE0505552 and owned by Apollo Endosurgery, Inc.. The device was registered on March 10, 2021.
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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