Covidien Valleylab FT10 FT series Energy Platform
- 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
- Risk class
- Class D
- Product owner
- Covidien llc
- Registrant / registration holder
- MEDTRONIC INTERNATIONAL, LTD. (Singapore Branch)
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 address
- 15 Hampshire Street, Mansfield, MA, 02048, United States
- Registrant address
- 50 PASIR PANJANG ROAD, #04-51, MAPLETREE BUSINESS CITY, Singapore 117384
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.