ApprovalTrail

Medical device licence · 103823 · Class 2

STEALTH AUTOGUIDE SYSTEM

Yes: licensed in Canada

Licence status Issued (active); first licensed November 4, 2019. It is in Health Canada’s list of active licences.
Licence number
103823
Licence holder
Medtronic Navigation, Inc.Lafayette, CO, United States
Risk class
Class II (low to moderate risk)
Licence type
System
First licensed
November 4, 2019
Devices covered
29

Devices on this licence

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

  • AUTOGUIDE BLUNT DRILL GUIDE
  • AUTOGUIDE BURR HOLE DRILL GUIDE
  • AUTOGUIDE BURR HOLE REDUCING TUBE
  • AUTOGUIDE CONTROL UNIT
  • AUTOGUIDE GUIDING JOINT
  • AUTOGUIDE HEAD CLAMP ADAPTER
  • AUTOGUIDE LOWER GUIDING INSERT
  • AUTOGUIDE POSITIONING ARM
  • AUTOGUIDE POWER AND NETWORK UNIT
  • AUTOGUIDE SEEG REDUCING TUBE
  • AUTOGUIDE STAB BIOPSY REDUCING TUBE
  • AUTOGUIDE STAB INCISION DRILL GUIDE
  • AUTOGUIDE STAB INCISION HEIGHT GUIDE
  • AUTOGUIDE STAB INCISION OBTURATOR
  • AUTOGUIDE STRAIN RELIEF BOX
  • AUTOGUIDE TAPPING TUBE
  • AUTOGUIDE TARGETING UNIT
  • AUTOGUIDE TARGETING UNIT CABLE SET
  • AUTOGUIDE UPPER GUIDING INSERT
  • AUTOGUIDE VISUALASE DRILL GUIDE
  • AUTOGUIDE VISUALASE HEIGHT GUIDE
  • AUTOGUIDE VISUALASE OBTURATOR
  • AUTOGUIDE VISUALASE REDUCING TUBE
  • GUIDING INSERTS
  • INSTRUMENT SET, AUTOGUIDE
  • INSTRUMENT SET, VISUALASE
  • STEALTH AUTOGUIDE II, INSTRUMENT SET
  • STEALTH AUTOGUIDE SYSTEM
  • STEALTH AUTOGUIDE TRACKER

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