Singapore HSA registration DE0017690
Boston Scientific Visual-ICE® Cryoablation System
Singapore·CLASS C·Boston Scientific Coporation·Registered December 01, 2015Device classification
- Device Class
- CLASS C
- Medical Speciality Area
- General & Plastic Surgery
Registration information
- Registration Number
- DE0017690
- Registration Date
- December 01, 2015
- Change Notification Approval Date
- March 13, 2025
- Retention Due Date
- November 30, 2025
Product description
The Boston Scientific Visual-ICE Cryoablation System is intended for cryoablative destruction of tissue during minimally invasive procedures; various Galil Medical accessory products are required to perform these procedures. The Visual-ICE System is indicated for use as a cryosurgical tool in the fields of general surgery, dermatology, neurology (including cryoanalgesia), thoracic surgery, ENT, gynecology, oncology, proctology, and urology. This system is designed to destroy tissue (including prostate and kidney tissue, liver metastases, tumors, skin lesions, and warts) by the application of extremely cold temperatures.
Product Owner
- Short Name
- Boston Scientific Coporation
- Address
- 300 Boston Scientific Way, Marlborough, MA01752-1234, UNITED STATES
Registrant
- Address
- 9 NORTH BUONA VISTA DRIVE, THE METROPOLIS TOWER ONE, #20-01, SINGAPORE 138588
Importer
- Address
- 9 NORTH BUONA VISTA DRIVE, THE METROPOLIS TOWER ONE, #20-01, SINGAPORE 138588 1 SIMS LANE, ONE SIMS LANE, #05-12, SINGAPORE 387355
Model information
- Model Name(s)
- USB Flash Drive Visual‐ICE® Cryoablation System IceRod® 1.5 CX 90° Cryoablation Needle IcePEARL® 2.1 CX 90° Cryoablation Needle IceFORCE® 2.1 CX 90° Cryoablation Needle IcePEARL® 2.1 CX Cryoablation Needle IceFORCE® 2.1 CX Cryoablation Needle IceSeed® 1.5 Cryoablation Needle IceSeed® 1.5 90° Cryoablation Needle IceRod® 1.5 PLUS 90° Cryoablation Needle IceSphere® 1.5 Cryoablation Needle IceSphere® 1.5 90° Cryoablation Needle IceSphere® 1.5 S 90° Cryoablation Needle Galil Medical Urethral Warming Set Multi‐Point 1.5 Thermal Sensor™ Five IceSphere™ Prostate Cryoablation Kit (5 needles) Five IceRod™ i-Thaw™ Prostate Cryoablation Kit (5 needles) IceRod™ i-Thaw™ Prostate Cryoablation Kit (8 needles) IceFORCE™ 2.1 CX Prostate Cryoablation Kit (6 needles) IcePearl™ 2.1 CX Prostate Cryoablation Kit (6 needles) Three IceFORCE™ 2.1 CX Prostate Cryoablation Kit (3 needles) Three IcePearl™ 2.1 CX Prostate Cryoablation Kit (3 needles) EZ CONNECT2™ Dual Cylinder Adapter, bar EZ CONNECT2™ Dual Cylinder Adapter, bar IceSeed™ Prostate Cryoablation Kit (14 needles) IceRod® 1.5 i‐Thaw® Cryoablation Needle IceRod® 1.5 Cryoablation Needle IceRod® 1.5 PLUS Cryoablation Needle
- Model Identifier(s)
- FPRCH6110 H7493960960000 H7493961435330 H7493961636010 H7493961736020 H7493961836030 H7493961936040 H7493962232010 H7493962332020 H7493962435080 H7493962535580 H7493962635600 H7493962735610 H7493963240030 H7493963340100 H7493963435700 H7493963535710 H7493963635720 H7493963736050 H7493963836060 H7493963936070 H7493964036080 H7493964340050 H7493964340080 H7493964845180 H7493964940090 H7493966332030 H7493967135100
About this record
Access comprehensive regulatory information for Boston Scientific Visual-ICE® Cryoablation 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 DE0017690 and owned by Boston Scientific Coporation. The device was registered on December 01, 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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