Singapore HSA registration DE0009167
Ethicon Endo-Surgery Generator G11 System
Singapore·CLASS C·Ethicon Endo-Surgery, LLC·Registered May 17, 2012Device classification
- Device Class
- CLASS C
- Medical Speciality Area
- General & Plastic Surgery
- HSA Product Code
- Refer to CRPNS
- HS Code
- 90189030
Registration information
- Registration Number
- DE0009167
- Registration Date
- May 17, 2012
- Change Notification Approval Date
- March 07, 2025
- Retention Due Date
- May 16, 2025
Product description
The Generator G11 provides radiofrequency power to drive EnSeal electrosurgical instruments that are used during open or laparoscopic general and gynecological surgery to cut and seal vessels and to cut, grasp, and dissect tissues. In addition, the generator provides power to drive Harmonic ultrasonic surgical instruments that are indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired.
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
Model information
- Model Name(s)
- Generator G11 HARMONIC® 1100 Shears, 20cm length HARMONIC® 1100 Shears, 36cm length Harmonic FOCUS Long Shears + Adaptive Tissue Technology HARMONIC ACE® 5 mm Diameter Shears 23 cm Length + Adaptive Tissue HARMONIC ACE® 5 mm Diameter Shears 36 cm Length + Adaptive Tissue HARMONIC™ 700 Shears, 23cm Shaft Length HARMONIC™ 700 Shears, 36cm Shaft Length HARMONIC™ 700 Shears, 45cm Shaft Length Harmonic FOCUS™ Shears + Adaptive Tissue Technology HARMONIC ACE+7 Shears With Advanced Hemostasis HARMONIC ACE+7 Laparoscopic Shears With Advanced Hemostasis HARMONIC ACE+7 Laparoscopic Shears With Advanced Hemostasis HARMONIC HD 1000i Shears, 20 cm Length HARMONIC HD 1000i Shears, 36 cm Length HARMONIC OSTEOVUE Spine Soft Tissue Dissector
- Model Identifier(s)
- GEN11 HAR1120 HAR1136 HAR17F HAR23 HAR36 HAR723 HAR736 HAR745 HAR9F HARH23 HARH36 HARH45 HARHD20 HARHD36 HARSB
About this record
Access comprehensive regulatory information for Ethicon Endo-Surgery Generator G11 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 DE0009167 and owned by Ethicon Endo-Surgery, LLC. The device was registered on May 17, 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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