Singapore HSA registration DE0019526
Ethicon Endo-Surgery Enseal® X1 Large Jaw Tissue Sealer
Singapore·CLASS C·Ethicon Endo-Surgery, LLC·Registered August 22, 2017Device classification
- Device Class
- CLASS C
- Medical Speciality Area
- General & Plastic Surgery
Registration information
- Registration Number
- DE0019526
- Registration Date
- August 22, 2017
- Change Notification Approval Date
- October 23, 2024
- Retention Due Date
- August 21, 2025
Product description
The ENSEAL X1 Large Jaw Tissue Sealer instrument is a dedicated bipolar electrosurgical instrument intended for use in open surgical procedures where ligation and division of vessels is desired. It is a bipolar instrument for use with the Ethicon Generator G11 (GEN11). It is intended for use during open surgery to cut and seal vessels, cut, grasp, and dissect tissue during surgery. Indications for use include open general, gynecologic, urologic, and thoracic procedures. These procedures include hysterectomies, colectomies, Nissen fundoplication, adhesiolysis, oophorectomies. The devices can be used on vessels (arteries, veins, pulmonary vasculature, lymphatics) up to and including 7 mm and tissue bundles.
Product Owner
- Short Name
- Ethicon Endo-Surgery, LLC
- Address
- 475 Calle C, Guaynabo, Puerto Rico, 00969, UNITED STATES
Registrant
- Address
- 2 SCIENCE PARK DRIVE, ASCENT, #07-13, SINGAPORE 118222
Importer
- Address
- 2 SCIENCE PARK DRIVE, ASCENT, #07-13, SINGAPORE 118222 2 SCIENCE PARK DRIVE, ASCENT, #07-13, SINGAPORE 118222
Model information
- Model Name(s)
- ENSEAL® X1 Large Jaw Tissue Sealer, 20cm Shaft Length
- Model Identifier(s)
- NSLX120L
About this record
Access comprehensive regulatory information for Ethicon Endo-Surgery Enseal® X1 Large Jaw Tissue Sealer in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0019526 and owned by Ethicon Endo-Surgery, LLC. The device was registered on August 22, 2017.
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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