Data / Medical devices / Japan / TSK Laboratory, Japan
TSK Laboratory, Japan: FDA-registered device maker in Tochigi-Shi, Japan, 1 510(k) clearance
TSK Laboratory, Japan is registered with the FDA (registration 3012854006) in Tochigi-Shi, Japan. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated April 10, 1997. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3012854006
- Address
- 1510-1 Soja-Machi, Tochigi-Shi, Japan, 328-0002
- Owner or operator
- TSK LABORATORY, JAPAN (9008437)
- Roles
- Complaint file establishment, Manufacturer, Specification developer
- First device listed
- July 16, 2008
- Registered through
- 2027
- Brand names listed
- CSH Cannula, STERiGLIDE, Steriject, Sterijekt
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Cannula, Surgical, General & Plastic Surgery | GEA | 1 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Needle, Hypodermic, Single Lumen | FMI | 2 | Complaint file establishment, Manufacturer, Specification developer | 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 |
|---|---|---|---|---|---|---|
| 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
Updated April 10, 1997. 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.