Medical device licence · 110206 · Class 2
BIPOLAR ELECTROSURGICAL GENERATOR
Yes: licensed in Canada
Licence status Issued (active); first licensed October 24, 2023. It is in Health Canada’s list of active licences.
- Licence number
- 110206
- Licence holder
- Kirwan Surgical Products, LlcMarshfield, MA, United States
- Risk class
- Class II (low to moderate risk)
- Licence type
- System
- First licensed
- October 24, 2023
- Devices covered
- 4
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- DUAL FOOTSWITCH
- POLARIS BIPOLAR ELECTROSURGICAL GENERATOR
- POLARIS IRRIGATION MODULE
- POLARIS LIGHT SOURCE MODULE
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.