Singapore HSA registration DE0009692
Ethicon Endo-Surgery ENSEAL G2 Tissue Sealers
Device classification
- Device Class
- CLASS C
- Medical Speciality Area
- General Hospital
- HSA Product Code
- Refer to CRPNS
- HS Code
- 90189030
Registration information
- Registration Number
- DE0009692
- Registration Date
- August 30, 2012
- Change Notification Approval Date
- May 08, 2025
- Retention Due Date
- August 29, 2025
Product description
are indicated for bipolar coagulation and mechanical transaction of tissue during laparoscopic and open procedures. The devices are bipolar electrosurgical instruments for use with an electrosurgical generator. They are intended for use during open or laparoscopic, general and gynecological surgery to cut and seal vessels, and to cut, grasp and dissect during surgery. Indications for use include open and laparoscopic, general and gynecological surgical procedures (including urologic, thoracic, plastic and reconstructive, bowel resections, hysterectomies, cholecystectomies, gall bladder procedures, Nissen fundoplication, adhesiolysis, oophorectomies, etc.), or any procedure where vessel ligation (cutting and sealing), tissue grasping and dissection is performed. The device can be used on vessels up to (and including) 7mm and bundles as large as will fit in the jaws of the instruments. The ENSEAL G2 Tissue Sealers have not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures. Do not use these devices for these procedures.
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 Tissue Sealer G2, Curved Jaw, 5mm, 14cm Enseal Tissue Sealer G2, Curved Jaw, 5mm, 25cm Enseal Laparoscopic Tissue Sealer G2, Curved Jaw, 5mm, 35cm Enseal Laparoscopic Tissue Sealer G2, Articulating Curved Jaw, 5mm, 35cm Enseal Laparoscopic Tissue Sealer G2, Curved Jaw, 5mm, 45cm Enseal Laparoscopic Tissue Sealer G2, Articulating Curved Jaw, 5mm, 45cm Enseal Tissue Sealer G2, Straight Jaw, 5mm, 14cm Enseal Tissue Sealer G2, Straight Jaw, 5mm, 25cm Enseal Laparoscopic Tissue Sealer G2, Straight Jaw, 5mm, 35cm Enseal Laparoscopic Tissue Sealer G2, Articulating Straight Jaw, 5mm, 35cm Enseal Laparoscopic Tissue Sealer G2, Straight Jaw, 5mm, 45cm Enseal Laparoscopic Tissue Sealer G2, Articulating Straight Jaw, 5mm, 45cm
- Model Identifier(s)
- NSLG2C14 NSLG2C25 NSLG2C35 NSLG2C35A NSLG2C45 NSLG2C45A NSLG2S14 NSLG2S25 NSLG2S35 NSLG2S35A NSLG2S45 NSLG2S45A
About this record
Access comprehensive regulatory information for Ethicon Endo-Surgery ENSEAL G2 Tissue Sealers in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0009692 and owned by Ethicon Endo-Surgery, LLC. The device was registered on August 30, 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.
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