Medical device licence · 422 · Class 3
ENDOBUTTON
Yes: licensed in Canada
Licence status Issued (active); first licensed December 14, 1998. It is in Health Canada’s list of active licences.
- Licence number
- 422
- Licence holder
- Smith & Nephew, Inc. EndoscopyAndover, MA, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- Device Group Family
- First licensed
- December 14, 1998
- Devices covered
- 3
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- ENDOBUTTON CL BTB FIXATION BUTTON
- ENDOBUTTON CL ULTRA FIXATION BUTTON
- ENDOBUTTON FIXATION BUTTON
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 “endobutton”. A notice may cover another product or only some lots: read it to see what it covers.
- ENDOBUTTON CL (2016-02-03)February 22, 2016 · Medical devices · Medical devices · Type III
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.