Medical device licence · 94088 · Class 3
SHOCKPULSE-SE LITHOTRIPSY SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed October 16, 2014. It is in Health Canada’s list of active licences.
- Licence number
- 94088
- Licence holder
- Gyrus Acmi, IncWestborough, MA, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- October 16, 2014
- Devices covered
- 9
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- SHOCKPULSE LITHOTRIPSY CLEANING STYLET
- SHOCKPULSE LITHOTRIPSY FOOT SWITCH
- SHOCKPULSE LITHOTRIPSY GENERATOR
- SHOCKPULSE LITHOTRIPSY NOSE CONE
- SHOCKPULSE LITHOTRIPSY POWER CORD
- SHOCKPULSE LITHOTRIPSY PROBE SET, REUSABLE
- SHOCKPULSE LITHOTRIPSY PROBE SET, STERILE SINGLE USE
- SHOCKPULSE LITHOTRIPSY TRANSDUCER
- SHOCKPULSE-SE LITHOTRIPSY SYSTEM
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 “shockpulse-se”. A notice may cover another product or only some lots: read it to see what it covers.
- ShockPulse-Se Lithotripsy System and ShockPulse Lithotripsy GeneratorJanuary 29, 2026 · Gastroenterology and urology · Performance · Type II
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.