Medical device licence · 75834 · Class 3
SMARTSTITCH SUTURING DEVICE
Yes: licensed in Canada
Licence status Issued (active); first licensed December 10, 2007. It is in Health Canada’s list of active licences.
- Licence number
- 75834
- Licence holder
- Arthrocare CorporationAustin, TX, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- December 10, 2007
- Devices covered
- 3
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- SMARTSTITCH SUTURING DEVICE
- SMARTSTITCH SUTURING DEVICE - PERFECTPASSER CONNECTOR
- SMARTSTITCH SUTURING DEVICE - PERFECTPASSER MAGNUMWIRE SUTURE CARTRIDGES
Recalls and safety alerts that mention it
Health Canada’s recall notices do not carry licence numbers, so these are matched by name: notices whose title or product names “smartstitch”. A notice may cover another product or only some lots: read it to see what it covers.
- SmartStitch Suturing Device - PerfectPasser Connector (2019-02-21)March 8, 2019 · Medical devices · Medical devices · Type II
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.