Pure Global
Singapore HSA registration DE0009643

Echelon Flex 45 Powered Endopath Stapler Articulating Endoscopic Linear Cutter and Reloads

Singapore flagSingapore·CLASS D·Ethicon Endo-Surgery, LLC·Registered August 28, 2012
Device classification
Device Class
CLASS D
Medical Speciality Area
General & Plastic Surgery
HSA Product Code
HSAMDD00110
HS Code
90189090
Registration information
Registration Number
DE0009643
Registration Date
August 28, 2012
Change Notification Approval Date
September 29, 2024
Retention Due Date
August 27, 2025
Product description
The ECHELON™ families of endoscopic linear cutters are intended for transaction, resection, and/or creation of anastomoses. The instruments have application in multiple open or minimally invasive general, gynecologic, urologic, thoracic, and pediatric surgical procedures. They can be used with staple line or tissue buttressing materials. The instruments may also be used for transaction and resection of liver parenchyma (hepatic vasculature and biliary structures), pancreas, kidney and spleen.
Product Owner
Name
Ethicon Endo-Surgery, LLC
Short Name
Ethicon Endo-Surgery, LLC
Address
475 Calle C, Guaynabo, Puerto Rico, 00969, UNITED STATES
Registrant
Name
Johnson & Johnson International (Singapore) Pte Ltd
Address
2 SCIENCE PARK DRIVE, ASCENT, #07-13, SINGAPORE 118222
Importer
Name
JOHNSON & JOHNSON PTE LTD Johnson & Johnson International (Singapore) Pte Ltd
Address
2 SCIENCE PARK DRIVE, ASCENT, #07-13, SINGAPORE 118222 2 SCIENCE PARK DRIVE, ASCENT, #07-13, SINGAPORE 118222
Model information
Model Name(s)
Echelon™ 45 ENDOPATH® STAPLER Endoscopic Linear Cutter Reloads Blue Echelon™ 45 ENDOPATH® STAPLER Endoscopic Linear Cutter Reloads Gold Echelon™ 45 ENDOPATH® STAPLER Endoscopic Linear Cutter Reloads Green Echelon™ 45 ENDOPATH® STAPLER Endoscopic Linear Cutter Reloads Gray Echelon™ 45 ENDOPATH® STAPLER Endoscopic Linear Cutter Reloads White Echelon flex™45 Powered Endopath® Stapler Compact Articulating Endoscopic Linear Cutter Echelon flex™45 Powered Endopath® Stapler Long Articulating Endoscopic Linear Cutter Echelon flex™45 Powered Endopath® Stapler Articulating Endoscopic Linear Cutter
Model Identifier(s)
ECR45B ECR45D ECR45G ECR45M ECR45W PCE45A PLE45A PSE45A
About this record

Access comprehensive regulatory information for Echelon Flex 45 Powered Endopath Stapler Articulating Endoscopic Linear Cutter and Reloads in the Singapore medical device market through Pure Global AI's free database. This CLASS D medical device is registered under HSA registration number DE0009643 and owned by Ethicon Endo-Surgery, LLC. The device was registered on August 28, 2012.

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 DatabasePowered by Pure Global AIHSA Official DataCLASS D