Medical device licence · 98705 · Class 3
FMX FERROMAGNETIC SURGICAL SYSTEM
No longer licensed: cancelled: renewal not answered
Licence status Cancelled: renewal not answered; first licensed February 28, 2017; ended December 6, 2017. It is in Health Canada’s archive of licences no longer in force.
- Licence number
- 98705
- Licence holder
- Domain Surgical, Inc.Salt Lake City, UT, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- February 28, 2017
- Ended
- December 6, 2017
- Devices covered
- 7
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- DISPOSABLE POWER MODULE
- FMWAND 2 HANDPIECE WITH DISSECTING LOOP
- FMWAND 2 HANDPIECE WITH DISSECTING LOOP AND INTEGRATED SMOKE EVACUATION
- FMWAND 2 HANDPIECE WITH RESECTING LOOP
- FMWAND 2 HANDPIECE WITH RESECTING LOOP AND INTEGRATED SMOKE EVACUATION
- FMX G1 GENERATOR
- REUSABLE POWER MODULE
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.