Data / Medical devices / Canada / TSK Laboratory International, Canada
TSK Laboratory International, Canada: FDA-registered device maker in Vancouver British Columbia, Canada, 2 510(k) clearances
TSK Laboratory International, Canada is registered with the FDA (registration 3005288183) in Vancouver British Columbia, Canada. It lists 3 device types. The FDA files 2 510(k) clearances under its listings, the newest dated October 31, 2016. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3005288183
- Address
- 1686 West 75th Avenue, Vancouver British Columbia, Canada, V6P 6G2
- Owner or operator
- Johnson Global Medical Products Inc. (10060825)
- Roles
- Exporter to the US
- First device listed
- July 2, 2019
- Registered through
- 2026
- Brand names listed
- CSH Cannula, FOURTE Expander Fill System, STERiGLIDE, STERiJECT
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Cannula, Surgical, General & Plastic Surgery | GEA | 1 | Exporter to the US | accessdata.fda.gov |
| Needle, Hypodermic, Single Lumen | FMI | 2 | Exporter to the US | accessdata.fda.gov |
| Tissue Expander And Accessories | LCJ | U | Exporter to the US | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| October 31, 2016 | K161483 | Unger Quad Injector | LCJ | Substantially Equivalent | Stradis Healthcare | accessdata.fda.gov |
| April 10, 1997 | K970370 | TSK STERIJEKT PREMIUM DISPOSABLE HYPODERMIC NEEDLE | FMI | Substantially Equivalent | Tsk Laboratory, Japan | accessdata.fda.gov |
Compare with other makers
- All makers of Needle, Hypodermic, Single Lumen
- All makers of Cannula, Surgical, General & Plastic Surgery
- All makers of Tissue Expander And Accessories
Updated October 31, 2016. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.