Medical device licence · 113633 · Class 2
PRISTINE SUMMIT SINGLE-USE ARTHROSCOPE
Yes: licensed in Canada
Licence status Issued (active); first licensed July 8, 2025. It is in Health Canada’s list of active licences.
- Licence number
- 113633
- Licence holder
- Pristine Surgical, LlcManchester, NH, United States
- Risk class
- Class II (low to moderate risk)
- Licence type
- System
- First licensed
- July 8, 2025
- Devices covered
- 3
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- IMAGE PROCESSING UNIT (IPU)
- PRISTINE SURGICAL ARTHROSCOPE
- SUMMIT HI-FLO CANNULA
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.