Medical device licence · 60679 · Class 2
SPHINCTEROTOMES
Yes: licensed in Canada
Licence status Issued (active); first licensed October 4, 2002. It is in Health Canada’s list of active licences.
- Licence number
- 60679
- Licence holder
- Olympus Medical Systems Corp.Hachioji-Shi, 13, Japan
- Risk class
- Class II (low to moderate risk)
- Licence type
- Device Family
- First licensed
- October 4, 2002
- Devices covered
- 3
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- DISPOSABLE PAPILLOTOMY KNIFE
- DISPOSABLE TRIPLE LUMEN SPHINCTEROTOME
- REUSABLE SPHINCTEROTOMES
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.