Medical device licence · 99382 · Class 3
ARTHREX SYNERGY RF SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed July 5, 2017. It is in Health Canada’s list of active licences.
- Licence number
- 99382
- Licence holder
- Arthrex IncNaples, FL, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- July 5, 2017
- Devices covered
- 9
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- APOLLO RF HOOK, NON-ASPIRATING 90 DEGREES
- APOLLO RF MP90, ASPIRATING ABLATOR 90 DEGREES, MULTI-PORT
- APOLLO RF XL90, ASPIRATING ABLATOR 90 DEGREES, EXTRA LARGE
- APOLLORF H50, ASPIRATING ABLATOR 50DEGREE
- APOLLORF I90, ASPIRATING ABLATOR 90 DEGREES
- APOLLORF MP50, ASPIRATING ABLATOR 50DEGREE, MULTI-PORT
- APOLLORF SJ50, ASPIRATING ABLATOR 50 DEGREE, SHORT
- SYNERGY RF CONSOLE
- SYNERGY RF FOOTSWITCH
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.