Data / Medical devices / Japan / Kaneka Medix Corporation Kanagawa Plant
Kaneka Medix Corporation Kanagawa Plant: FDA-registered device maker in Ashigara-Kami-gun Kanagawa, Japan, 2 510(k) clearances
Kaneka Medix Corporation Kanagawa Plant is registered with the FDA (registration 3009761573) in Ashigara-Kami-gun Kanagawa, Japan. It lists 3 device types. The FDA files 2 510(k) clearances under its listings, the newest dated March 26, 2021. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3009761573
- Address
- 225-1 Aza Deguchi, Yamakita Yamakita-machi, Ashigara-Kami-gun Kanagawa, Japan, 2580113
- Owner or operator
- KANEKA CORP. (9005249)
- Roles
- Manufacturer
- First device listed
- April 19, 2017
- Registered through
- 2026
- Brand names listed
- EDG v4, Lacriflow CL, i-ED COIL
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Device, Neurovascular Embolization | HCG | 2 | Manufacturer | accessdata.fda.gov |
| Device, Vascular, For Promoting Embolization | KRD | 2 | Manufacturer | accessdata.fda.gov |
| Lacrimal Stents And Intubation Sets | OKS | U | Manufacturer | 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 |
|---|---|---|---|---|---|---|
| March 26, 2021 | K210638 | i-ED COIL System | HCG | Substantially Equivalent | Kaneka Medical America, LLC | accessdata.fda.gov |
| April 18, 2017 | K170247 | Lacriflow CL | OKS | Substantially Equivalent | Kaneka Pharma America, LLC | accessdata.fda.gov |
Compare with other makers
- All makers of Device, Vascular, For Promoting Embolization
- All makers of Device, Neurovascular Embolization
- All makers of Lacrimal Stents And Intubation Sets
Updated March 26, 2021. 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.