HSA · registration DE0510653Covidien Valleylab™ SM Smoke Management Pencils
- Registration number
- DE0510653
- Model name
- Valleylab™ SM Smoke Management Extended Nozzle, for use with 4” electrode; Valleylab™ SM Smoke Management Extended Nozzle, for use with 6.5” electrode; Valleylab™ SM Smoke Management Pencil with Edge™ Blade Electrode, 10’; Valleylab™ SM Smoke Management Pencil with Edge™ Blade Electrode, 15’
- Model identifier
- VSMEN4; VSMEN6; VSMP10; VSMP15
- Registration date
- April 30, 2025
- Risk class
- Class C
- Product owner
- COVIDIEN LLC
- Registrant / registration holder
- COVIDIEN PRIVATE LIMITED
The intended purpose is to cut and coagulate tissue while removing surgical smoke. The Valleylab™ SM Smoke Management Pencil and accessories are designed for general electrosurgical applications, including cutting and coagulation, and for removing surgical smoke generated by electrosurgery when used in conjunction with an effective smoke evacuation system. The pencil enables the operator to remotely conduct an electrosurgical current from the output connector of an electrosurgical unit to the operative site for the desired surgical effect.
- Product owner address
- 15 Hampshire Street, Mansfield, Massachusetts, 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.