Medical device licence · 37300 · Class 2
PLASMAKINETIC SURGICAL ELECTRODES
Yes: licensed in Canada
Licence status Issued (active); first licensed April 9, 2002. It is in Health Canada’s list of active licences.
- Licence number
- 37300
- Licence holder
- Gyrus Acmi, IncWestborough, MA, United States
- Risk class
- Class II (low to moderate risk)
- Licence type
- Device Family
- First licensed
- April 9, 2002
- Devices covered
- 16
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- LYONS PLASMAKINETIC DISSECTING FORCEPS
- PK BUTTON FRONT LOADING ELECTRODE
- PKS PLASMA J-HOOK WITH CORD
- PKS PLASMASPATULA WITH CORD
- PKS SEAL OPEN FORCEPS, CURVED JAW WITH CORD
- PLASMAKINECT SUPERLOOP LOOP DEVICE
- PLASMAKINECT SUPERSECT WIDE LOOP DEVICE
- PLASMAKINETIC CURVED JAW OPEN FORCEPS
- PLASMAKINETIC CUTTING FORCEPS
- PLASMAKINETIC FORCEPS MACRO-JAW
- PLASMAKINETIC MOLLY FORCEPS
- PLASMAKINETIC NEEDLE ELECTRODE
- PLASMAKINETIC PLASMA
- PLASMAKINETIC SUPRA SPATULA ELECTRODE
- SUPERLOOP PK FRONT LOADING ELECTRODE
- SUPERSECT PK FRONT LOADING ELECTRODE
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.