Medical device licence · 2735 · Class 3
PROXIMATE STAPLING DEVICES
Yes: licensed in Canada
Licence status Issued (active); first licensed April 29, 1999. It is in Health Canada’s list of active licences.
- Licence number
- 2735
- Licence holder
- Ethicon Endo-Surgery, LlcCincinnati, OH, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- Device Group Family
- First licensed
- April 29, 1999
- Devices covered
- 10
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- PROXIMATE ACCESS 55 ARTICULATING LINEAR STAPLER
- PROXIMATE LINEAR CUTTER RELOADING UNITS
- PROXIMATE PLUS MD MULTI-DIRECTIONAL RELEASE SKIN STAPLER
- PROXIMATE PPH PROCEDURE FOR PROLAPSE AND HEMORRHOIDS SET
- PROXIMATE RELOADABLE LINEAR CUTTER WITH SAFETY
- PROXIMATE RELOADABLE LINEAR FOUR ROW STAPLER W/SAFETY LOCK-OUT
- PROXIMATE RH ROTATING HEAD SKIN STAPLER
- PROXIMATE SKIN STAPLE EXTRACTOR
- PROXIMATE SKIN STAPLER
- PROXIMATE TX LINEAR STAPLER
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 “proximate”. A notice may cover another product or only some lots: read it to see what it covers.
- PROXIMATE ILS Intraluminal Stapler, Endopath ILS Endoscopic Circular Stapler (2019-03-28)April 12, 2019 · Medical devices · Medical devices · Type II
- PROXIMATE HCS Hemorrhoidal Circular Stapler and PROXIMATE PPH Procedure for Prolapse and Hemorrhoids Set (2018-12-11)January 9, 2019 · Medical devices · Medical devices · Type II
- Proximate PPH Hemorrhoidal Circular Stapler and Accessories 33MMAugust 20, 2012 · Medical devices · Type II
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.