Medical device licence · 78833 · Class 2
ENSEAL ELECTRODES
Yes: licensed in Canada
Licence status Issued (active); first licensed January 14, 2009. It is in Health Canada’s list of active licences.
- Licence number
- 78833
- Licence holder
- Ethicon Endo-Surgery, LlcCincinnati, OH, United States
- Risk class
- Class II (low to moderate risk)
- Licence type
- Device Family
- First licensed
- January 14, 2009
- Devices covered
- 3
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- ENSEAL SYSTEM - TAPTRONIC ELECTRODES ROUND TIP
- ENSEAL SYSTEM - TAPTRONIC STD TIP TISSUE SEALING ELECTRODES
- ENSEAL SYSTEM - TAPTRONIC TRIO CURVED ROUND TIP TISSUE SEALING ELECTRODES
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 “enseal”. A notice may cover another product or only some lots: read it to see what it covers.
- ENSEAL X1 Tissue Sealer (2019-05-13)May 31, 2019 · Medical devices · Medical devices · Type II
- Enseal ProductsDecember 24, 2012 · Medical devices · Type II
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.