Singapore HSA registration DE0017055
Ethicon Endo-Surgery Echelon ENDOPATH Endoscopic Linear Cutter Reloads with Gripping Surface Technology
Singapore·CLASS D·Ethicon Endo-Surgery, LLC·Registered April 20, 2015Device classification
- Device Class
- CLASS D
- Medical Speciality Area
- General & Plastic Surgery
Registration information
- Registration Number
- DE0017055
- Registration Date
- April 20, 2015
- Change Notification Approval Date
- January 28, 2025
- Retention Due Date
- April 19, 2026
Product description
The ECHELON FLEX™, ECHELON™ 3000, and ECHELON ENDOPATH™ families of staplers and reloads are intended for transection, resection, and/or creation of anastomoses. The instruments have application in multiple open or minimally invasive general, urologic, thoracic, and pediatric surgical procedures. They can be used with staple line or tissue reinforcement materials. The instruments may also be used for transection and resection of liver parenchyma (hepatic vasculature and biliary structures), pancreas, kidney, and spleen.
Product Owner
- Short Name
- Ethicon Endo-Surgery, LLC
- Address
- 475 Calle C, 00969 Guaynabo, PUERTO RICO, UNITED STATES
Registrant
- Address
- 2 SCIENCE PARK DRIVE, ASCENT, #07-13, SINGAPORE 118222
Importer
- Address
- 2 SCIENCE PARK DRIVE, ASCENT, #07-13, SINGAPORE 118222
Model information
- Model Name(s)
- Echelon 3000 45mm Compact Stapler Echelon 3000 45mm Long Stapler Echelon 3000 45mm Standard Staple Echelon 3000 60mm Compact Stapler Echelon 3000 60mm Long Stapler Echelon 3000 60mm Standard Stapler ECHELON ENDOPATH™ Reloads with Gripping Surface Technology, Blue, 45 mm, 3.6 mm, 6 Rows ECHELON ENDOPATH™ Reloads with Gripping Surface Technology, Gold, 45 mm, 3.8 mm, 6 Rows ECHELON ENDOPATH™ Reloads with Gripping Surface Technology, Green, 45 mm, 4.1 mm, 6 Rows ECHELON ENDOPATH™ Reloads with Gripping Surface Technology, Black, 45 mm, 4.2 mm, 6 Rows ECHELON ENDOPATH™ Reloads with Gripping Surface Technology, White, 45 mm, 2.6 mm, 6 Rows ECHELON ENDOPATH™ Reloads with Gripping Surface Technology, Blue, 60 mm, 3.6 mm, 6 Rows ECHELON ENDOPATH™ Reloads with Gripping Surface Technology, Gold, 60 mm, 3.8 mm, 6 Rows ECHELON ENDOPATH™ Reloads with Gripping Surface Technology, Green, 60 mm, 4.1 mm, 6 Rows ECHELON ENDOPATH™ Reloads with Gripping Surface Technology, Black, 60 mm, 4.2 mm, 6 Rows ECHELON ENDOPATH™ Reloads with Gripping Surface Technology, White, 60 mm, 2.6 mm, 6 Rows ECHELON FLEX™ Powered Plus Compact Articulating Endoscopic Linear Cutter, 45mm Staple Line, 280mm Shaft Length ECHELON FLEX™ Powered Plus Compact Articulating Endoscopic Linear Cutter, 60mm Staple Line, 280mm Shaft Length ECHELON FLEX™ Powered Plus Long Articulating Endoscopic Linear Cutter, 45mm Staple Line, 440mm Shaft Length ECHELON FLEX™ Powered Plus Long Articulating Endoscopic Linear Cutter, 60mm Staple Line, 440mm Shaft Length ECHELON FLEX™ Powered Plus Articulating Endoscopic Linear Cutter, 45mm Staple Line, 340mm Shaft Length ECHELON FLEX™ Powered Plus Articulating Endoscopic Linear Cutter, 60mm Staple Line, 340mm Shaft Length
- Model Identifier(s)
- ECH45C ECH45L ECH45S ECH60C ECH60L ECH60S GST45B GST45D GST45G GST45T GST45W GST60B GST60D GST60G GST60T GST60W PCEE45A PCEE60A PLEE45A PLEE60A PSEE45A PSEE60A
About this record
Access comprehensive regulatory information for Ethicon Endo-Surgery Echelon ENDOPATH Endoscopic Linear Cutter Reloads with Gripping Surface Technology in the Singapore medical device market through Pure Global AI's free database. This CLASS D medical device is registered under HSA registration number DE0017055 and owned by Ethicon Endo-Surgery, LLC. The device was registered on April 20, 2015.
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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