ApprovalTrail

Medical device licence · 80426 · Class 2

RE-USABLE SPHINCTEROTOMES

No longer licensed: discontinued at renewal

Licence status Discontinued at renewal; first licensed August 7, 2009; ended November 27, 2017. It is in Health Canada’s archive of licences no longer in force.
Licence number
80426
Licence holder
Endo-Flex GmbhVoerde, 05, Germany
Risk class
Class II (low to moderate risk)
Licence type
Device Group Family
First licensed
August 7, 2009
Ended
November 27, 2017
Devices covered
10

Devices on this licence

By name, as listed. The official record lists model numbers and identifiers.

  • GUIDE WIRE SPHINCTEROTOMES (RE-USABLE) 2.2 MM, SINGLE LUMEN, PRECUT TYPE
  • GUIDE WIRE SPHINCTEROTOMES (RE-USABLE) 2.2 MM, SINGLE LUMEN, TAPERED TIP
  • SPHINCTEROTOMES NON-GUIDE-WIRE (RE-USABLE) 1.8 MM DIAMETER
  • SPHINCTEROTOMES NON-GUIDE-WIRE (RE-USABLE) 1.8 MM, SINGLE LUMEN PRECUT TYPE
  • SPHINCTEROTOMES NON-GUIDE-WIRE (RE-USABLE) 1.8 MM, SINGLE LUMEN TAPERED TIP
  • SPHINCTEROTOMES NON-GUIDE-WIRE (RE-USABLE) 1.8 SINGLE LUMEN PRECUT TAPERED
  • SPHINCTEROTOMES NON-GUIDE-WIRE (RE-USABLE) 2.2 DOUBLE, NEEDLE KNIFE POINTED
  • SPHINCTEROTOMES NON-GUIDE-WIRE (RE-USABLE) 2.2 MM DOUBLE LUMEN STANDARD TIP
  • SPHINCTEROTOMES NON-GUIDE-WIRE (RE-USABLE) 2.2 MM DOUBLE LUMEN TAPERED TIP
  • SPHINCTEROTOMES NON-GUIDE-WIRE (RE-USABLE) 2.2 MM, DOUBLE LUMEN PRECUT TYPE

Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.