Pure Global

Apollo Endosurgery OverStitch™ Endoscopic Suturing System - HSA Registration DE0505551

Access comprehensive regulatory information for Apollo Endosurgery OverStitch™ 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 DE0505551 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.

Free Database
Powered by Pure Global AI
HSA Official Data
CLASS C
DE0505551
Apollo Endosurgery OverStitch™ Endoscopic Suturing System
HSA Registration Number: DE0505551
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
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.

Device Classification
Device Class
CLASS C
Medical Speciality Area
Gastroenterology & Urology
Registration Information
Registration Number
DE0505551
Registration Date
March 10, 2021
Change Notification Approval Date
November 07, 2024
Retention Due Date
March 09, 2026
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™ Endoscopic Suturing System OverStitch™ 2-0 Polypropylene Suture Tissue Helix
Model Identifier(s)
CNH-G01-000 ESS-G02-160 PLY-G02-020-APL THX-165-028