Singapore HSA registration DE0505861
Covidien Valleylab FT10 FT series Energy Platform
Device classification
- Device Class
- CLASS D
- Medical Speciality Area
- Cardiovascular
Registration information
- Registration Number
- DE0505861
- Registration Date
- June 10, 2021
- Change Notification Approval Date
- September 30, 2024
- Retention Due Date
- June 09, 2025
Product description
The Valleylab™ FT10 Energy Platform is a high frequency electrosurgical generator intended for use with monopolar and bipolar accessories for cutting and coagulating tissue. When used with compatible sealing devices, it is indicated for sealing vessels up to and including 7 mm, tissue bundles, and lymphatics. When used with compatible ablation devices it is indicated for cardiac tissue ablation. The generator can also be used with compatible resectoscopes for endoscopically controlled removal or coagulation of tissue using 0.9% NaCl solution as the irrigation medium. The tissue fusion function has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures. Do not use this function for these procedures.
Product Owner
- Name
- Covidien llc
- Short Name
- Covidien llc
- Address
- 15 Hampshire Street, Mansfield, MA, 02048, UNITED STATES
Registrant
- Address
- 50 PASIR PANJANG ROAD, MAPLETREE BUSINESS CITY, #04-51, SINGAPORE 117384
Importer
- Address
- 50 PASIR PANJANG ROAD, MAPLETREE BUSINESS CITY, #04-51, SINGAPORE 117384 50 PASIR PANJANG ROAD, MAPLETREE BUSINESS CITY, #04-51, SINGAPORE 117384
Model information
- Model Name(s)
- Cardioblate™ Pen Cardioblate™ XL Pen Cardioblate™ BP2 Device Cardioblate™ BP2 System Cardioblate™ LP Device Cardioblate™ LP System Cardioblate™ Gemini™-s Surgical Ablation Device Valleylab FT10
- Model Identifier(s)
- 49313 49314 49321 49322 49341 49342 49351 VLFT10GEN
About this record
Access comprehensive regulatory information for Covidien Valleylab FT10 FT series Energy Platform in the Singapore medical device market through Pure Global AI's free database. This CLASS D medical device is registered under HSA registration number DE0505861 and owned by Covidien llc. The device was registered on June 10, 2021.
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.
Free DatabasePowered by Pure Global AIHSA Official DataCLASS D