Data / Medical devices / Japan / Mitaka Kohki Co., Ltd.
Mitaka Kohki Co., Ltd.: FDA-registered device maker in MITAKA SHI Tokyo, Japan, 2 510(k) clearances
Mitaka Kohki Co., Ltd. is registered with the FDA (registration 3003713161) in MITAKA SHI Tokyo, Japan. It lists 3 device types. The FDA files 2 510(k) clearances under its listings, the newest dated July 6, 2009. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3003713161
- Address
- 1-18-8 Nozaki, MITAKA SHI Tokyo, Japan, 181-0014
- Owner or operator
- MITAKA KOHKI CO., LTD. (9035807)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- November 19, 2007
- Registered through
- 2027
- Brand names listed
- HawkSight, Mitaka KestrelView, Mitaka KestrelView II, Mitaka MM51 SS1, Mitaka MM51 YOH, Mitaka MM77 SOH, Mitaka MM80 SOH, Mitaka MM80 SS1 and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Endoscope, Neurological | GWG | 2 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Laparoscope, General & Plastic Surgery | GCJ | 2 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Microscope, Surgical | EPT | 1 | Contract manufacturer, 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 |
|---|---|---|---|---|---|---|
| July 6, 2009 | K090792 | MITAKA UNIARM | GCJ | Substantially Equivalent | Mitaka Kohki Co., Ltd. | accessdata.fda.gov |
| April 1, 1999 | K984355 | POINT SETTER | GCJ | Substantially Equivalent | Mitaka USA, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Microscope, Surgical
- All makers of Endoscope, Neurological
- All makers of Laparoscope, General & Plastic Surgery
Updated July 6, 2009. 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.