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HSA · registration DE0505861

Covidien Valleylab FT10 FT series Energy Platform

SingaporeCardiovascularClass DCovidien llc
Official record identity
Registration number
DE0505861
Model name
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
49313; 49314; 49321; 49322; 49341; 49342; 49351; VLFT10GEN
Registration date
June 10, 2021
Source update date
September 11, 2025
Classification
Risk class
Class D
Official value: CLASS D
Published category
Cardiovascular
Published parties
Product owner
Covidien llc
Official 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.

Additional source fields
Product owner address
15 Hampshire Street, Mansfield, MA, 02048, United States
Registrant address
50 PASIR PANJANG ROAD, #04-51, MAPLETREE BUSINESS CITY, Singapore 117384
About this record

This page mirrors one row from HSA’s official registered-medical-device workbook. Product owner and registrant are separate published roles; neither is relabeled as the manufacturer. The official NOT_GENERATED value is retained when HSA does not publish a registration number, and the device name remains part of the stable record identity.