Data / Medical devices / Japan / TSK Laboratory International Japan KK
TSK Laboratory International Japan KK: FDA-registered device maker in Tochigi, Japan, 4 510(k) clearances
TSK Laboratory International Japan KK is registered with the FDA (registration 9681387) in Tochigi, Japan. It lists 5 device types. The FDA files 4 510(k) clearances under its listings, the newest dated October 23, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 9681387
- FEI number
- 3002808401
- Address
- 2 Chome 1-5 Hirayanagi-Machi, Tochigi, Japan, 328-0012
- Owner or operator
- TSK Laboratory International Japan KK (10083590)
- Roles
- Exporter to the US, Manufacturer
- First device listed
- December 3, 2021
- Registered through
- 2026
- Brand names listed
- FOURTE Expander Fill System, STERiGLIDE, STERiJECT, STERiJECT Low Dead Space, STERiJECT Ophthalmic Needle, STERiJECT Ophthalmic Needle Low Dead Space (LDS), STERiJECT The Invisible Needle, STERiJEKT
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Cannula, Surgical, General & Plastic Surgery | GEA | 1 | Manufacturer | accessdata.fda.gov |
| Low Dead Space Needle, Single Lumen, Hypodermic | QNS | 2 | Manufacturer | accessdata.fda.gov |
| Needle, Hypodermic, Single Lumen | FMI | 2 | Manufacturer | accessdata.fda.gov |
| Ophthalmic Needle | QYM | 2 | Manufacturer | 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 23, 2024 | K242073 | STERiJECT Ophthalmic Needle; STERiJECT Ophthalmic Needle Low Dead Space (LDS) | QYM | Substantially Equivalent | Tsk Laboratory International Japan KK | accessdata.fda.gov |
| March 8, 2024 | K231734 | STERiJECT Low Dead Space, STERiJECT The Invisible Needle | QNS | Substantially Equivalent | Tsk Laboratory International Japan KK | accessdata.fda.gov |
| 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 Tissue Expander And Accessories
- All makers of Low Dead Space Needle, Single Lumen, Hypodermic
- All makers of Cannula, Surgical, General & Plastic Surgery
- All makers of Ophthalmic Needle
Updated October 23, 2024. 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.