Data / Medical devices / Japan / Ispg Japan Co., Ltd.
Ispg Japan Co., Ltd.: FDA-registered device maker in Tokyo, Japan, 2 510(k) clearances
Ispg Japan Co., Ltd. is registered with the FDA (registration 3012334073) in Tokyo, Japan. It lists 2 device types. The FDA files 2 510(k) clearances under its listings, the newest dated October 15, 2001. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3012334073
- Address
- 4-2-10 Asakusabashi Taito-ku, Tokyo, Japan, 111-0053
- Owner or operator
- ISPG Japan Co., Ltd. (10051937)
- Roles
- Exporter to the US
- First device listed
- May 22, 2016
- Registered through
- 2026
- Brand names listed
- Chiba Procedure Needle, Spinal and Epidural Needles
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Biopsy Needle | FCG | 2 | Exporter to the US | accessdata.fda.gov |
| Needle, Conduction, Anesthetic (W/Wo Introducer) | BSP | 2 | 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 15, 2001 | K012358 | CHIBA NEEDLE | FCG | Substantially Equivalent | Ispg, Inc. | accessdata.fda.gov |
| October 9, 1996 | K962886 | ANESTHESIA CONDUCTION NEEDLE | BSP | Substantially Equivalent | Ispg, Inc. | accessdata.fda.gov |
Compare with other makers
Updated October 15, 2001. 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.